Preventative and Therapeutic Probiotic Use in Allergic Skin Conditions: Experimental and Clinical Findings

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Özdemir, Öner; Göksu Erol, Azize Yasemin

2013-01-01

Probiotics are ingested live microbes that can modify intestinal microbial populations in a way that benefits the host. The interest in probiotic preventative/therapeutic potential in allergic diseases stemmed from the fact that probiotics have been shown to improve intestinal dysbiosis and permeability and to reduce inflammatory cytokines in human and murine experimental models. Enhanced presence of probiotic bacteria in the intestinal microbiota is found to correlate with protection against allergy. Therefore, many studies have been recently designed to examine the efficacy of probiotics, but the literature on the allergic skin disorders is still very scarce. Here, our objective is to summarize and evaluate the available knowledge from randomized or nonrandomized controlled trials of probiotic use in allergic skin conditions. Clinical improvement especially in IgE-sensitized eczema and experimental models such as atopic dermatitis-like lesions (trinitrochlorobenzene and picryl chloride sensitizations) and allergic contact dermatitis (dinitrofluorobenzene sensitization) has been reported. Although there is a very promising evidence to recommend the addition of probiotics into foods, probiotics do not have a proven role in the prevention or the therapy of allergic skin disorders. Thus, being aware of possible measures, such as probiotics use, to prevent/heal atopic diseases is essential for the practicing allergy specialist. PMID:24078929

A Gastroenterologist’s Guide to Probiotics

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Ciorba, Matthew A

2012-01-01

The enteric microbiota contributes to gastrointestinal health and its disruption has been associated with many disease states. Some patients consume probiotic products in attempts to manipulate the intestinal microbiota for health benefit. It is important for gastroenterologists to improve their understanding of the mechanisms of probiotics and the evidence that support their use in practice. Clinical trials have assessed the therapeutic effects of probiotics for several disorders, including antibiotic-or Clostridium difficile-associated diarrhea, irritable bowel syndrome, and the inflammatory bowel diseases. Although probiotic research is a rapidly evolving field, there are sufficient data to justify a trial of probiotics for treatment or prevention of some of these conditions. However, the capacity of probiotics to modify disease symptoms is likely to be modest and varies among probiotic strains—not all probiotics are right for all diseases. The current review provides condition-specific rationale for using probiotics as therapy and literature-based recommendations. PMID:22504002

Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial.

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Heczko, Piotr B; Tomusiak, Anna; Adamski, Paweł; Jakimiuk, Artur J; Stefański, Grzegorz; Mikołajczyk-Cichońska, Aleksandra; Suda-Szczurek, Magdalena; Strus, Magdalena

2015-12-03

This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV). Patients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5-6 (I, II, II bis - if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18-50-year-old women who were randomised. BV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment. This study demonstrated that oral probiotics lengthened remission in

Probiotics for the management of neonatal hyperbilirubinemia: a systematic review of randomized controlled trials.

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Deshmukh, Janki; Deshmukh, Mangesh; Patole, Sanjay

2017-08-31

Neonatal jaundice requiring phototherapy is associated with significant socioeconomic burden including hospital readmission, prolonged hospital stay, and separation of the baby from mother. To assess the efficacy and safety of probiotics in reducing the need for phototherapy and its duration in neonatal hyperbilirubinemia. A systematic review of randomized controlled trials (RCTs) of probiotic supplementation for prevention or treatment of jaundice in neonates (any gestation or weight) using the Cochrane methodology. Primary outcome was the duration of phototherapy. Secondary outcomes included incidence of jaundice, total serum bilirubin (TSB) level at 24, 48, 72, 96 h, and day 7, duration of hospital stay, and adverse effects (e.g. probiotic sepsis). Results were summarized as per GRADE guidelines. Nine RCTs (prophylactic: six trials, N = 1761; therapeutic: three trials, N = 279) with low to high risk of bias were included. Meta-analysis (random-effects model) showed probiotic supplementation reduced duration of phototherapy [N = 415, mean difference (MD): -11.80 (-17.47, -6.13); p probiotic treatment. Prophylactic probiotics did not reduce the incidence of jaundice significantly [N = 1582, relative risk (RR): 0.56 (0.25, 1.27); p = .16; LOE: low]. There were no probiotic-related adverse effects. Limited low-quality evidence indicates that probiotic supplementation may reduce the duration of phototherapy in neonates with jaundice. Routine use of probiotics to prevent or treat neonatal jaundice cannot be recommended. Large well-designed trials are essential to confirm these findings.

Efficacy of a probiotic and chlorhexidine mouth rinses: A short-term clinical study

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Harini P

2010-09-01

Full Text Available Introduction: Probiotic technology represents a breakthrough approach to maintaining oral health by utilizing natural beneficial bacteria commonly found in healthy mouths to provide a natural defense against those bacteria thought to be harmful to teeth and gums. However, data are still sparse on the probiotic action in the oral cavity. The review article on probiotics in children published by Twetman and Stecksen- Blicks in 2008 showed only one study of dental interest on probiotics in children. Aim and Objectives: The present study evaluated clinically the efficacy of a probiotic and chlorhexidine mouth rinses on plaque and gingival accumulation in children. The trial design is a double-blind parallel group, 14 days comparative study between a probiotic mouth rinse and a chlorhexidine mouth rinse, which included 45 healthy children in the age group of 6-8 years. Results: The Probiotic and Chlorhexidine groups had less plaque accumulations compared with the Control group at the end of 14 years (P < 0.001 and P < 0.001, respectively. But, unlike the plaque score, there was a significant difference in the Gingival Index between the Probiotic and the Chlorhexidine groups (P = 0.009, Probiotic group being better than the Chlorhexidine group (mean = 0.2300 and 0.6805, respectively. Conclusion: The Probiotic mouth rinse was found effective in reducing plaque accumulation and gingival inflammation. Therefore, probiotic mouth rinse obviously has a potential therapeutic value and further long-term study is recommended to determine its efficacy.

The Mexican consensus on probiotics in gastroenterology

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M.A. Valdovinos; E. Montijo; A.T. Abreu; S. Heller; A. González-Garay; D. Bacarreza; M. Bielsa-Fernández; M.C. Bojórquez-Ramos; F. Bosques-Padilla; A.I. Burguete-García; R. Carmona-Sánchez; A. Consuelo-Sánchez; E. Coss-Adame; J.A. Chávez-Barrera; M. de Ariño

2017-01-01

Introduction: Probiotics are frequently prescribed in clinical practice. Their efficacy in treating gastrointestinal disorders is supported by a significant number of clinical trials. However, the correct prescription of these agents is hampered due to a lack of knowledge of the scientific evidence and to the different presentations and microbial compositions of the probiotics that are currently available. Aim: To provide the clinician with a consensus review of probiotics and recommendati...

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

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Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials

Can probiotics enhance vaccine-specific immunity in children and adults?

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Kwak, J Y; Lamousé-Smith, E S N

2017-10-13

The growing use of probiotics by the general public has heightened the interest in understanding the role of probiotics in promoting health and preventing disease. General practitioners and specialists often receive inquiries from their patients regarding probiotic products and their use to ward off systemic infection or intestinal maladies. Enhanced immune function is among the touted health benefits conferred by probiotics but has not yet been fully established. Results from recent clinical trials in adults suggest a potential role for probiotics in enhancing vaccine-specific immunity. Although almost all vaccinations are given during infancy and childhood, the numbers of and results from studies using probiotics in pediatric subjects are limited. This review evaluates recent clinical trials of probiotics used to enhance vaccine-specific immune responses in adults and infants. We highlight meaningful results and the implications of these findings for designing translational and clinical studies that will evaluate the potential clinical role for probiotics. We conclude that the touted health claims of probiotics for use in children to augment immunity warrant further investigation. In order to achieve this goal, a consensus should be reached on common study designs that apply similar treatment timelines, compare well-characterised probiotic strains and monitor effective responses against different classes of vaccines.

Systematic review and meta-analysis of randomized trials on probiotics for hepatic encephalopathy

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Holte, Kathrine; Krag, Aleksander; Gluud, Lise Lotte

2012-01-01

Aim:  The objective of this systematic review and meta-analysis was to assess the efficacy of probiotics and synbiotics in patients with hepatic encephalopathy. Methods:  Eligible trials were identified by searching electronic databases including MEDLINE, the Cochrane Library, Science Citation...... Index and Embase, abstract proceedings, reference lists and ongoing trial registers until 13 October 2010. We included randomized controlled trials comparing probiotics and synbiotics with no intervention, placebo or lactulose in patients with hepatic encephalopathy. The primary outcome measure...... was improvement in hepatic encephalopathy. Results were expressed as risk rates (RR) with confidence intervals (CI) and intertrial heterogeneity as I(2) . Results:  Seven trials with a total of 393 patients were analyzed. Compared to placebo or lactulose, treatment with probiotics or synbiotics significantly...

Systematic review of randomized controlled trials of probiotics, prebiotics, and synbiotics in inflammatory bowel disease

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Ghouri YA

2014-12-01

Full Text Available Yezaz A Ghouri, David M Richards, Erik F Rahimi, Joseph T Krill, Katherine A Jelinek, Andrew W DuPont The University of Texas Medical School at Houston, Houston, Texas, USA Background: Probiotics are microorganisms that are ingested either in combination or as a single organism in an effort to normalize intestinal microbiota and potentially improve intestinal barrier function. Recent evidence has suggested that inflammatory bowel disease (IBD may result from an inappropriate immunologic response to intestinal bacteria and a disruption in the balance of the gastrointestinal microbiota in genetically susceptible individuals. Prebiotics, synbiotics, and probiotics have all been studied with growing interest as adjuncts to standard therapies for IBD. In general, probiotics have been shown to be well-tolerated with few side effects, making them a potential attractive treatment option in the management of IBD. Aim: To perform a systematic review of randomized controlled trials on the use of probiotics, prebiotics, and synbiotics in IBD. Results: In our systematic review we found 14 studies in patients with Crohn’s disease (CD, 21 studies in patients with ulcerative colitis (UC, and five studies in patients with pouchitis. These were randomized controlled trials using probiotics, prebiotics, and/or synbiotics. In patients with CD, multiple studies comparing probiotics and placebo showed no significant difference in clinical outcomes. Adding a probiotic to conventional treatment improved the overall induction of remission rates among patients with UC. There was also a similar benefit in maintaining remission in UC. Probiotics have also shown some efficacy in the treatment of pouchitis after antibiotic-induced remission. Conclusions: To date, there is insufficient data to recommend probiotics for use in CD. There is evidence to support the use of probiotics for induction and maintenance of remission in UC and pouchitis. Future quality studies are

Probiotics for photoprotection.

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Guéniche, Audrey; Philippe, David; Bastien, Philippe; Blum, Stephanie; Buyukpamukcu, Elif; Castiel-Higounenc, Isabelle

2009-09-01

Specific strains of probiotic, have been identified as beneficial to influence the composition and/or metabolic activity of the endogenous microbiota and some of these strains have been also shown to inhibit the growth of a wide range of enteropathogens. The first aim of using probiotics has been to improve the composition of the intestinal microbiota from a potentially harmful composition towards a composition that would be beneficial to the host.Beyond their capacity to influence positively the composition of the intestinal microbiota, several lines of evidence suggest that some probiotic bacteria can modulate the immune system both at the local and systemic levels thereby improving immune defense mechanisms and/or downregulate immune disorders such as allergies or intestinal inflammation.Skin reflects the general health status and aging. Different human trials widely suggest that probiotic supplementation might be useful in the management of atopic dermatitis. Based on these properties it appears that, beyond the gut, probiotics might exert their benefits at the skin level.In a randomized double blind placebo-controlled clinical trial, we investigated whether the probiotic bacteria Lactobacillus johnsonii NCC 533 (La1) could modulate the cutaneous immune homeostasis altered by solar-simulated UV exposure in humans. After, UV exposure to twice 1.5 MED, we demonstrated that La1 intake facilitated an earlier recovery of Epidermal cells allostimulatory function. Thus, this clinical data strengthen the assumption that certain probiotics can contribute to modulate skin immune system leading to the preservation of the skin homeostasis. Altogether the data affords the possibility of designing new strategies based on a nutritional approach for the prevention of UV-induced damaging effects.

Influence of consumption of probiotics on the plasma lipid profile: a meta-analysis of randomised controlled trials.

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Guo, Z; Liu, X M; Zhang, Q X; Shen, Z; Tian, F W; Zhang, H; Sun, Z H; Zhang, H P; Chen, W

2011-11-01

Human clinical studies have yielded mixed results on the effects of consumption of probiotics on the plasma lipid profile. We conducted a meta-analysis of randomised controlled trials that evaluated the effects of probiotics consumption on blood lipids. A systematic literature search of Embase, Web of Science, PubMed and Cochrane Controlled Trials Registry was conducted for studies that investigated the efficacy of probiotics on the plasma lipid profile of subjects. With the help of Review Manager 4.2, data from 13 trials, which included 485 participants with high, borderline high and normal cholesterol levels, were examined. The pooled mean net change in total cholesterol for those treated with probiotics compared to controls was -6.40 mg dl(-1) (95% confidence interval (CI), -9.93 to -2.87), mean net change in low-density lipoprotein (LDL) cholesterol was -4.90 mg dl(-1) (95% CI, -7.91 to -1.90), mean net change in high-density lipoprotein (HDL) cholesterol was -0.11 mg dl(-1) (95% CI, -1.90-1.69) and mean net change in triglycerides was -3.95 mg dl(-1) (95% CI, -10.32-2.42). These results indicate that a diet rich in probiotics decreases total cholesterol and LDL cholesterol concentration in plasma for participants with high, borderline high and normal cholesterol levels. Copyright © 2011 Elsevier B.V. All rights reserved.

Probiotics for caries prevention and control

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Twetman, S; Keller, M K

2012-01-01

Modulation of the microbiota for restoring and maintaining health is a growing issue in medical science. A search for relevant clinical trials on the use of probiotic bacteria as a potential and clinically applicable anti-caries measure was performed. According to predetermined criteria, papers...... of heterogeneity among the included investigations hampered the analysis. Significant reductions of mutans streptococci in saliva or plaque following daily intake of probiotic lactobacilli or bifidobacteria were reported in 12 out of 19 papers, whereas 3 reported an increase of lactobacilli. Three caries trials...... in preschool children and the elderly demonstrated prevented fractions of between 21% and 75% following regular intakes of milk supplemented with L. rhamnosus. No adverse effects or potential risks were reported. The currently available literature does not exclude the possibility that probiotic bacteria can...

Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up

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Alicia Morales

2018-01-01

Full Text Available ABSTRACT Objective: The aim of this double-blind, placebo-controlled and parallel- arm randomized clinical trial was to evaluate the effects of Lactobacillus rhamnosus SP1-containing probiotic sachet and azithromycin tablets as an adjunct to nonsurgical therapy in clinical parameters and in presence and levels of Tannerella forsythia, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Material and Methods: Forty-seven systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically and microbiologically at baseline for 3, 6 and 9 months after therapy. Subgingival plaque samples were collected from four periodontal sites with clinical attachment level ≥1 mm, probing pocket depth ≥4 mm and bleeding on probing, one site in each quadrant. Samples were cultivated and processed using the PCR technique. Patients received nonsurgical therapy including scaling and root planing (SRP and were randomly assigned to a probiotic (n=16, antibiotic (n = 16 or placebo (n = 15 group. L. rhamnosus SP1 was taken once a day for 3 months. Azithromycin 500mg was taken once a day for 5 days. Results: All groups showed improvements in clinical and microbiological parameters at all time points evaluated. Probiotic and antibiotic groups showed greater reductions in cultivable microbiota compared with baseline. The placebo group showed greater reduction in number of subjects with P. gingivalis compared with baseline. However, there were no significant differences between groups. Conclusions: The adjunctive use of L. rhamnosus SP1 sachets and azithromycin during initial therapy resulted in similar clinical and microbiological improvements compared with the placebo group.

Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up

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Morales, Alicia; Gandolfo, Alessandro; Bravo, Joel; Carvajal, Paola; Silva, Nora; Godoy, Claudia; Garcia-Sesnich, Jocelyn; Hoare, Anilei; Diaz, Patricia; Gamonal, Jorge

2018-01-01

ABSTRACT Objective The aim of this double-blind, placebo-controlled and parallel- arm randomized clinical trial was to evaluate the effects of Lactobacillus rhamnosus SP1-containing probiotic sachet and azithromycin tablets as an adjunct to nonsurgical therapy in clinical parameters and in presence and levels of Tannerella forsythia, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Material and Methods Forty-seven systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically and microbiologically at baseline for 3, 6 and 9 months after therapy. Subgingival plaque samples were collected from four periodontal sites with clinical attachment level ≥1 mm, probing pocket depth ≥4 mm and bleeding on probing, one site in each quadrant. Samples were cultivated and processed using the PCR technique. Patients received nonsurgical therapy including scaling and root planing (SRP) and were randomly assigned to a probiotic (n=16), antibiotic (n = 16) or placebo (n = 15) group. L. rhamnosus SP1 was taken once a day for 3 months. Azithromycin 500mg was taken once a day for 5 days. Results All groups showed improvements in clinical and microbiological parameters at all time points evaluated. Probiotic and antibiotic groups showed greater reductions in cultivable microbiota compared with baseline. The placebo group showed greater reduction in number of subjects with P. gingivalis compared with baseline. However, there were no significant differences between groups. Conclusions The adjunctive use of L. rhamnosus SP1 sachets and azithromycin during initial therapy resulted in similar clinical and microbiological improvements compared with the placebo group. PMID:29364340

Is there a role for modified probiotics as beneficial microbes: a systematic review of the literature.

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Zorzela, L; Ardestani, S K; McFarland, L V; Vohra, S

2017-10-13

Our objective was to conduct a systematic review and meta-analysis for the use of modified (heat-killed or sonicated) probiotics for the efficacy and safety to prevent and treat various diseases. Recent clinical research has focused on living strains of probiotics, but use in high-risk patients and potential adverse reactions including bacteremia has focused interest on alternatives to the use of live probiotics. We searched MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL, Alt Health Watch, Web of Science, Scopus, PubMed, from inception to February 14, 2017 for randomised controlled trials involving modified probiotic strains. The primary outcome was efficacy to prevent or treat disease and the secondary outcome was incidence of adverse events. A total of 40 trials were included (n=3,913): 14 trials (15 arms with modified probiotics and 20 control arms) for the prevention of diseases and 26 trials (29 arms with modified probiotics and 32 control arms) for treatment of various diseases. Modified microbes were compared to either placebo (44%), or the same living probiotic strain (39%) or to only standard therapies (17%). Modified microbes were not significantly more or less effective than the living probiotic in 86% of the preventive trials and 69% of the treatment trials. Modified probiotic strains were significantly more effective in 15% of the treatment trials. Incidence rates of adverse events were similar for modified and living probiotics and other control groups, but many trials did not collect adequate safety data. Although several types of modified probiotics showed significant efficacy over living strains of probiotics, firm conclusions could not be reached due to the limited number of trials using the same type of modified microbe (strain, daily dose and duration) for a specific disease indication. Further research may illuminate other strains of modified probiotics that may have potential as clinical biotherapeutics.

The ProPrems trial: investigating the effects of probiotics on late onset sepsis in very preterm infants

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Opie Gillian

2011-08-01

establish full enteral feeds, duration of hospital stay, growth measurements at 6 and 12 months' corrected age and evidence of atopic conditions at 12 months' corrected age. Discussion Results from previous studies on the use of probiotics to prevent diseases in preterm infants are promising. However, a large clinical trial is required to address outstanding issues regarding safety and efficacy in this vulnerable population. This study will address these important issues. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN012607000144415 The product "ABC Dophilus Probiotic Powder for Infants®", Solgar, USA has its 3 probiotics strains registered with the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ - German Collection of Microorganisms and Cell Cultures as BB-12 15954, B-02 96579, Th-4 15957.

Probiotics for the treatment of bacterial vaginosis.

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Senok, Abiola C; Verstraelen, Hans; Temmerman, Marleen; Botta, Giuseppe A

2009-10-07

The dominance of lactobacilli in healthy vaginal microbiota and its depletion in bacterial vaginosis (BV) has given rise to the concept of oral or vaginal instillation of probiotic Lactobacillus strains for the management of this condition. To ascertain the efficacy of probiotics in the treatment of BV. We searched electronic databases irrespective of publication status or language. These included: Cochrane Central Register of Controlled Trials (CENTRAL), the HIV/AIDS and STD Cochrane Review Groups' specialized registers, the Cochrane Complementary Medicine Field's Register of Controlled Trials, MEDLINE (1966 to 2008), EMBASE (1980 to 2007), ISI science citation index (1955 to 2007), CINAHL (Cumulative Index to Nursing & Allied Health Literature (1982 to 2007).We handsearched of specialty journals, conference proceedings and publications list on the website of the International Scientific Association of Probiotics and Prebiotics (http://www.isapp.net/default.asp).For unpublished studies or ongoing trials, we contacted authors from relevant publications, nutraceutical companies and probiotic-related scientific associations. We searched electronic databases on ongoing clinical trials. Randomized controlled trials using probiotics for the treatment of women of any age diagnosed with bacterial vaginosis, regardless of diagnostic method used. The probiotic preparation could be single or "cocktail" of strains, any preparation type/dosage/route of administration. Studies comparing probiotics with placebo, probiotics used in conjunction with conventional antibiotics compared with placebo or probiotics alone compared with conventional antibiotics were eligible for inclusion. We screened titles and abstracts , obtained full reports of relevant trialsand independently appraised them for eligibility. A data extraction form was used to extract data from the four included studies. For dichotomous outcomes, odds ratios (OR) and 95% confidence intervals (CI) were derived for each

The Role of Probiotic Lactic Acid Bacteria and Bifidobacteria in the Prevention and Treatment of Inflammatory Bowel Disease and Other Related Diseases: A Systematic Review of Randomized Human Clinical Trials

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Maria Jose Saez-Lara

2015-01-01

Full Text Available Inflammatory bowel disease (IBD, which includes Crohn’s disease (CD and ulcerative colitis (UC, is a chronic inflammation of the small intestine and colon caused by a dysregulated immune response to host intestinal microbiota in genetically susceptible subjects. A number of fermented dairy products contain lactic acid bacteria (LAB and bifidobacteria, some of which have been characterized as probiotics that can modify the gut microbiota and may be beneficial for the treatment and the prevention of IBD. The objective of this review was to carry out a systematic search of LAB and bifidobacteria probiotics and IBD, using the PubMed and Scopus databases, defined by a specific equation using MeSH terms and limited to human clinical trials. The use of probiotics and/or synbiotics has positive effects in the treatment and maintenance of UC, whereas in CD clear effectiveness has only been shown for synbiotics. Furthermore, in other associated IBD pathologies, such as pouchitis and cholangitis, LAB and bifidobacteria probiotics can provide a benefit through the improvement of clinical symptoms. However, more studies are needed to understand their mechanisms of action and in this way to understand the effect of probiotics prior to their use as coadjuvants in the therapy and prevention of IBD conditions.

A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women.

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Jordan E Bisanz

Full Text Available A lactobacilli dominated microbiota in most pre and post-menopausal women is an indicator of vaginal health. The objective of this double blinded, placebo-controlled crossover study was to evaluate in 14 post-menopausal women with an intermediate Nugent score, the effect of 3 days of vaginal administration of probiotic L. rhamnosus GR-1 and L. reuteri RC-14 (2.5×109 CFU each on the microbiota and host response. The probiotic treatment did not result in an improved Nugent score when compared to when placebo. Analysis using 16S rRNA sequencing and metabolomics profiling revealed that the relative abundance of Lactobacillus was increased following probiotic administration as compared to placebo, which was weakly associated with an increase in lactate levels. A decrease in Atopobium was also observed. Analysis of host responses by microarray showed the probiotics had an immune-modulatory response including effects on pattern recognition receptors such as TLR2 while also affecting epithelial barrier function. This is the first study to use an interactomic approach for the study of vaginal probiotic administration in post-menopausal women. It shows that in some cases multifaceted approaches are required to detect the subtle molecular changes induced by the host to instillation of probiotic strains.ClinicalTrials.gov NCT02139839.

Probiotics and Irritable Bowel Syndrome

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Riitta Korpela

2012-06-01

Full Text Available Background: Irritable bowel syndrome (IBS is a major cause of abdominal discomfort and gut dysfunction worldwide. It is a poorly understood functional gastrointestinal disorder for which no effective medication is available. It is a benign condition, but its social and economic burden is significant. The symptoms consist of abdominal pain, bloating, flatulence, and irregular bowel movements. Alterations in the intestinal microbiota and mucosal inflammation may contribute to the development of IBS and probiotics could thus relieve the symptoms. This review gives an overview on the existing data on the effects of probiotics on the gastrointestinal symptoms of IBS. Methods: A PUBMED search was made to review the relevant literature, and additional studies were obtained from the references of the selected articles. Results: Clinical trials suggest that certain probiotics or combinations of bacteria have beneficial effects on the IBS symptoms. However the heterogeneity of studies, e.g. suboptimal study design, inadequate number of subjects, different doses and vehicles, inadequate length, make it difficult to compare the differences between probiotics and the effect may be strain-specific. Conclusions: Though evidence is very promising, no general recommendations on the use of probiotics in IBS can be given yet. Further clinical trials and data on the mechanisms of action are needed. Probiotics are considered safe and if future scientific data is able to substantiate their efficacy in IBS, they certainly could be a treatment option in relieving the symptoms in IBS.

Are Probiotics or Prebiotics useful in pediatric irritable bowel syndrome or inflammatory bowel disease?

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Stefano eGuandalini

2014-08-01

Full Text Available Treatment options for irritable bowel syndrome (IBS and inflammatory bowel disease (IBD are notoriously either inadequate (IBS or loaded with potentially serious side effects and risks (IBD. In recent years a growing interest for effective and safer alternatives has focused on the potential role of probiotics and their metabolic substrates, prebiotics. It is in fact conceivable that the microbiome might be targeted by providing the metabolic fuel needed for the growth and expansion of beneficial microorganisms (prebiotics or by administering to the host such microorganisms (probiotics. This review presents a concise update on currently available data, with a special emphasis on children.Data for prebiotics in IBS are scarce. Low doses have shown a beneficial effect, while high doses are counterproductive. On the contrary, several controlled trials of probiotics have yielded encouraging results. A meta-analysis including 9 randomized clinical trials in children showed an improvement in abdominal pain for Lactobacillus GG, Lactobacillus reuteri DSM 17938 and the probiotic mixture VSL#3. The patients most benefitting from probiotics were those with predominant diarrhea or with a post-infectious IBS. In IBD, the use of prebiotics has been tested only rarely and in small scale clinical trials, with mixed results. As for probiotics, data in humans from about 3 dozens clinical trials offer mixed outcomes. So far none of the tested probiotics has proven successful in Crohn’s disease, while in ulcerative colitis a recent meta-analysis on 12 clinical trials (1 of them in children showed efficacy for the probiotic mixture VSL#3 in contributing to induce and to maintain remission. It is evident that this is a rapidly evolving and promising field; more data are very likely to yield a better understanding on what strains and in what doses should be used in different specific clinical settings.

The impact of probiotics and n-3 long-chain polyunsaturated fatty acids on intestinal permeability in pregnancy: a randomised clinical trial.

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Mokkala, K; Pussinen, P; Houttu, N; Koivuniemi, E; Vahlberg, T; Laitinen, K

2018-02-27

A disruption in intestinal barrier integrity may predispose individuals to metabolic aberrations, particularly during the vulnerable period of pregnancy. We investigated whether intestinal permeability, as measured by serum zonulin concentration, changes over the duration of pregnancy and whether this change is reflected in lipopolysaccharide (LPS) activity. Second, we tested in a randomised double-blind placebo controlled clinical trial the impact of consuming dietary probiotics and/or long chain polyunsaturated fatty acid (LC-PUFA) supplements in lowering serum zonulin concentration and LPS activity. The probiotic supplement was a combination of two bacteria, Bifidobacterium animalis ssp. lactis 420 and Lactobacillus rhamnosus HN001. This study included 200 overweight pregnant women participating in an on-going study; participants were randomised to consume either (1) probiotics, (2) LC-PUFA, (3) probiotics and LC-PUFA, or (4) placebo for each supplement. Blood samples were obtained at early, the baseline, and late pregnancy (mean 14 and 35 weeks of gestation, respectively). Serum zonulin concentration increased from early (mean (standard deviation): 62.7 (12.9) ng/ml) to late pregnancy by 5.3 (95%CI 3.7-6.9) ng/ml, and LPS activity increased from (0.16 (0.04) EU/ml) by 0.04 (95%CI 0.03-0.05) EU/ml. No differences among the intervention groups were detected in the change from early to late pregnancy in serum zonulin concentration (P=0.8) or LPS activity (P=0.2). The change in serum zonulin concentration during the pregnancy was associated with the weeks of follow up (r=0.25, Pzonulin concentration or LPS activity.

Clinical Uses of Probiotics

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Islam, Saif Ul

2016-01-01

Abstract Probiotics are live nonpathogenic microorganisms. Many of these microorganisms are part of the normal human gut flora, where they live in a symbiotic relationship. Probiotics have been used to treat gastrointestinal (GI) and non-GI medical conditions. However, the data supporting their use are often conflicting, especially for non-GI-associated illnesses. The strongest evidence supporting the use of probiotics is related to the treatment of acute diarrhea and pouchitis. Atopic eczema in children and genitourinary infections are the only non-GI-related medical conditions where probiotics may have some beneficial effects. Product selection and dosing are not the same in all conditions, and the beneficial effects of each probiotic strain cannot be generalized. The purpose of this article is to provide most recent information about probiotics and its uses. In contrast with previously published reviews on probiotics, we also discuss the composition of various products (Table 1), indications for their use (Table 2), product selection, and dosing of probiotics. Probiotics are safe and appear to exert some beneficial effects in GI-related illnesses. The use of probiotics in non-GI illnesses is not sufficiently supported by current data. PMID:26844491

The Mexican consensus on probiotics in gastroenterology.

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Valdovinos, M A; Montijo, E; Abreu, A T; Heller, S; González-Garay, A; Bacarreza, D; Bielsa-Fernández, M; Bojórquez-Ramos, M C; Bosques-Padilla, F; Burguete-García, A I; Carmona-Sánchez, R; Consuelo-Sánchez, A; Coss-Adame, E; Chávez-Barrera, J A; de Ariño, M; Flores-Calderón, J; Gómez-Escudero, O; González-Huezo, M S; Icaza-Chávez, M E; Larrosa-Haro, A; Morales-Arámbula, M; Murata, C; Ramírez-Mayans, J A; Remes-Troche, J M; Rizo-Robles, T; Peláez-Luna, M; Toro-Monjaraz, E M; Torre, A; Urquidi-Rivera, M E; Vázquez, R; Yamamoto-Furusho, J K; Guarner, F

Probiotics are frequently prescribed in clinical practice. Their efficacy in treating gastrointestinal disorders is supported by a significant number of clinical trials. However, the correct prescription of these agents is hampered due to a lack of knowledge of the scientific evidence and to the different presentations and microbial compositions of the probiotics that are currently available. To provide the clinician with a consensus review of probiotics and recommendations for their use in gastroenterology. Controlled clinical trials, meta-analyses, and systematic reviews published up to 2015 were selected, using the MESH terms: probiotics, gastrointestinal diseases, humans, adults, AND children. The Delphi method was employed. Eighteen gastroenterologists treating adult patients and 14 pediatric gastroenterologists formulated statements that were voted on until agreement>70% was reached. The level of evidence based on the GRADE system was evaluated for each statement. Eleven statements on the general concepts of probiotics and 27 statements on the use of probiotics in gastrointestinal diseases in both adults and children were formulated. The consensus group recommends the use of probiotics under the following clinical conditions: the prevention of diarrhea associated with antibiotics, the treatment of acute infectious diarrhea, the prevention of Clostridium difficile infection and necrotizing enterocolitis, the reduction of adverse events from Helicobacter pylori eradication therapy, relief from irritable bowel syndrome symptoms, the treatment of functional constipation in the adult, and the induction and maintenance of remission in patients with ulcerative colitis and pouchitis, and the treatment of covert and overt hepatic encephalopathy. Copyright © 2016 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Probiotics for vulvovaginal candidiasis in non-pregnant women.

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Xie, Huan Yu; Feng, Dan; Wei, Dong Mei; Mei, Ling; Chen, Hui; Wang, Xun; Fang, Fang

2017-11-23

Vulvovaginal candidiasis (VVC) is estimated to be the second most common form of infection after bacterial vaginosis. The ability of probiotics in maintaining and recovering the normal vaginal microbiota, and their potential ability to resist Candidas give rise to the concept of using probiotics for the treatment of VVC. To assess the effectiveness and safety of probiotics for the treatment of vulvovaginal candidiasis in non-pregnant women. We searched the following databases to October 2017: Sexually Transmitted Infections Cochrane Review Group's Specialized Register, CENTRAL, MEDLINE, Embase and eight other databases. We searched in following international resources: World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, Web of Science and OpenGrey. We checked specialty journals, reference lists of published articles and conference proceedings. We collected information from pharmaceutical companies and experts in the field. Randomized controlled trials (RCT) using probiotics, alone or as adjuvants to conventional antifungal drugs, to treat VVC in non-pregnant women. Trials recruiting women with recurrent VVC, coinfection with other vulvovaginal infections, diabetes mellitus, immunosuppressive disorders or taking immunosuppressant medication were ineligible for inclusion. Probiotics were included if they were made from single or multiple species and in any preparation type/dosage/route of administration. Two review authors independently assessed trials for eligibility and quality and extracted data. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach. Ten RCTs (1656 participants) met our inclusion criteria, and pharmaceutical industry funded none of these trials. All trials used probiotics as adjuvant therapy to antifungal drugs. Probiotics increased the rate of short-term clinical cure (risk ratio (RR) 1.14, 95% confidence interval (CI) 1.05 to 1.24, 695

Systematic review: probiotics for functional constipation in children.

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Wojtyniak, Katarzyna; Szajewska, Hania

2017-09-01

We updated our 2010 systematic review on the efficacy of probiotics in the treatment of constipation in children. The MEDLINE, EMBASE, and Cochrane Library databases; clinical trial registries; and reference lists of included studies were searched to February 2017 for randomized controlled trials (RCTs) performed in children, with no language restriction. The primary outcome measure was treatment success, as defined by the investigators. We included seven RCTs with a total of 515 participants. Included trials were heterogeneous with respect to study population, probiotic strains, dosages, study duration, and follow-up. Pooled results of two RCTs showed no significant difference between the Lactobacillus rhamnosus casei Lcr35 and placebo groups with respect to treatment success. Other probiotics were studied in single trials only. There was no significant difference between the probiotic and control groups with respect to treatment success. While some probiotic strains showed some effects on defecation frequency, none of the probiotics had beneficial effects on frequency of fecal incontinence or frequency of abdominal pain. Adverse events were rare and not serious. Limited evidence does not support the use of any of currently evaluated probiotics in the treatment of functional constipation in children. What is Known: • Conventional treatment for functional constipation in children does not always provide satisfying improvement. • Probiotics have been suggested as potential treatment modalities for this condition. What is New: • Probiotics are ineffective for the management of functional constipation in children in terms of treatment success, frequency of fecal incontinence, and frequency of abdominal pain.

The Effect of Probiotic Yogurt on Blood Glucose and cardiovascular Biomarkers in Patients with Type II Diabetes: A Randomized Controlled Trial

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Mahin Rezaei

2017-01-01

Full Text Available Background: Given the high prevalence of type II diabetes and its complications, the evidence regarding the beneficial effects of probiotic yogurt on some cardiovascular biomarkers in diabetic patients is worthy of investigation. Aim: To investigate the effect of probiotic yogurt on blood glucose level and cardiovascular biomarkers in patients with type II diabetes. Method:This randomized, clinical trial was conducted on 90 patients with type II diabetes who visited the 5 Azar diabetes clinic in Gorgan, Iran, in 2014. The intervention group consumed three 100 g packages of probiotic yogurt per day for four weeks, while the control group used an equal amount of plain yogurt. Dietary intake, as well as anthropometric and biochemical parameters were measured before and after the trial. To analyze the data, independent t-test, paired t-test, and analysis of covariance were performed, using SPSS version 18. Results: The mean ages of the intervention and control groups were 50.49±10.92 and 50.13±9.20 years, respectively. In the intervention group, paired t-test showed significant differences between mean levels of blood glucose, cholesterol, low-density lipoprotein (LDL, triglycerides, diastolic blood pressure, and glycated hemoglobin before and after four weeks of daily intake of probiotic yogurt (P0.05. At the end of trial, the independent t-test showed a significant difference between the two groups in terms of mean levels of blood glucose, LDL, triglycerides, blood pressure, and glycated hemoglobin (P

The effects of probiotics on total cholesterol: A meta-analysis of randomized controlled trials.

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Wang, Lang; Guo, Mao-Juan; Gao, Qing; Yang, Jin-Feng; Yang, Lin; Pang, Xiao-Li; Jiang, Xi-Juan

2018-02-01

Probiotics supplements provide a new nonpharmacological alternative to reduce cardiovascular risk factors. The impact of probiotics on the reduction of total cholesterol (TC) remains controversial. We conducted a meta-analysis to showcase the most updated and comprehensive evaluation of the studies. Randomized controlled trials (RCTs) were searched from electronic databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang database dating from January 2007 to January 2017. The curative effects of probiotics on the reduction of TC were assessed using mean difference (MD), as well as their 95% confidence interval (CI). RevMan software (version 5.3) was used to carry out this meta-analysis. Thirty-two RCTs including 1971 patients met the inclusion criteria. Results of this analysis showed that compared with the control group serum TC was significantly reduced in probiotics group [MD = -13.27, 95% CI (-16.74 to 9.80), P  6 weeks: [MD = -22.18, 95% CI (-28.73, -15.63), P probiotics forms and intervention duration might have a significant impact on the results. However, strains and doses of probiotics had no significant influence on curative effects. Available evidence indicates that probiotics supplements can significantly reduce serum TC. Furthermore, higher baseline TC, longer intervention time, and probiotics in capsules form might contribute to a better curative effect.

Gut microbiota and probiotics: Focus on diabetes mellitus.

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Bordalo Tonucci, Livia; Dos Santos, Karina Maria Olbrich; De Luces Fortes Ferreira, Celia Lucia; Ribeiro, Sonia Machado Rocha; De Oliveira, Leandro Licursi; Martino, Hercia Stampini Duarte

2017-07-24

The characterization of gut microbiota has become an important area of research in several clinical conditions, including type 2 diabetes (T2DM). Changes in the composition and/or metabolic activity of the gut microbiota can contribute to human health. Thus, this review discusses the effects of probiotics and gut microbiota on metabolic control in these individuals. Relevant studies were obtained from electronic databases such as PubMed/Medline and ISI Web of Science. The main probiotics used in these studies belonged to the genera Lactobacillus and Bifidobacterium. The authors found seven randomized placebo-controlled clinical trials and 13 experimental studies directly related to the effect of probiotics on metabolic control in the context of T2DM. The hypothesis that gut microbiota plays a role in the development of diabetes indicates an important beginning, and the potential of probiotics to prevent and reduce the severity of T2DM is better observed in animal studies. In clinical trials, the use of probiotics in glycemic control presented conflicting results, and only few studies have attempted to evaluate factors that justify metabolic changes, such as markers of oxidative stress, inflammation, and incretins. Thus, further research is needed to assess the effects of probiotics in the metabolism of diabetic individuals, as well as the main mechanisms involved in this complex relationship.

Probiotics: an update

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Yvan Vandenplas

2015-02-01

Full Text Available OBJECTIVE: Triggered by the growing knowledge on the link between the intestinal microbiome and human health, the interest in probiotics is ever increasing. The authors aimed to review the recent literature on probiotics, from definitions to clinical benefits, with emphasis on children. SOURCES: Relevant literature from searches of PubMed, CINAHL, and recent consensus statements were reviewed. SUMMARY OF THE FINDINGS: While a balanced microbiome is related to health, an imbalanced microbiome or dysbiosis is related to many health problems both within the gastro-intestinal tract, such as diarrhea and inflammatory bowel disease, and outside the gastro-intestinal tract such as obesity and allergy. In this context, a strict regulation of probiotics with health claims is urgent, because the vast majority of these products are commercialized as food (supplements, claiming health benefits that are often not substantiated with clinically relevant evidence. The major indications of probiotics are in the area of the prevention and treatment of gastro-intestinal related disorders, but more data has become available on extra-intestinal indications. At least two published randomized controlled trials with the commercialized probiotic product in the claimed indication are a minimal condition before a claim can be sustained. Today, Lactobacillus rhamnosus GG and Saccharomyces boulardii are the best-studied strains. Although adverse effects have sporadically been reported, these probiotics can be considered as safe. CONCLUSIONS: Although regulation is improving, more stringent definitions are still required. Evidence of clinical benefit is accumulating, although still missing in many areas. Misuse and use of products that have not been validated constitute potential drawbacks.

Probiotic yogurt improves antioxidant status in type 2 diabetic patients.

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Ejtahed, Hanie S; Mohtadi-Nia, Javad; Homayouni-Rad, Aziz; Niafar, Mitra; Asghari-Jafarabadi, Mohammad; Mofid, Vahid

2012-05-01

Oxidative stress plays a major role in the pathogenesis and progression of diabetes. Among various functional foods with an antioxidant effect, probiotic foods have been reported to repress oxidative stress. The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients. Sixty-four patients with type 2 diabetes mellitus, 30 to 60 y old, were assigned to two groups in this randomized, double-blind, controlled clinical trial. The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk. Fasting blood samples, 24-h dietary recalls, and anthropometric measurements were collected at the baseline and at the end of the trial. Probiotic yogurt significantly decreased fasting blood glucose (P activities and total antioxidant status (P activity within either group (P > 0.05). The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients. These results suggest that probiotic yogurt is a promising agent for diabetes management. Copyright © 2012 Elsevier Inc. All rights reserved.

The effects of perioperative probiotic treatment on serum zonulin concentration and subsequent postoperative infectious complications after colorectal cancer surgery: a double-center and double-blind randomized clinical trial.

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Liu, Zhi-Hua; Huang, Mei-Jin; Zhang, Xing-Wei; Wang, Lei; Huang, Nan-Qi; Peng, Hui; Lan, Pin; Peng, Jun-Sheng; Yang, Zhen; Xia, Yang; Liu, Wei-Jie; Yang, Jun; Qin, Huan-Long; Wang, Jian-Ping

2013-01-01

Zonulin is a newly discovered protein that has an important role in the regulation of intestinal permeability. Our previous study showed that probiotics can decrease the rate of infectious complications in patients undergoing colectomy for colorectal cancer. The objective was to determine the effects of the perioperative administration of probiotics on serum zonulin concentrations and the subsequent effect on postoperative infectious complications in patients undergoing colorectal surgery. A total of 150 patients with colorectal carcinoma were randomly assigned to the control group (n = 75), which received placebo, or the probiotics group (n = 75). Both the probiotics and placebo were given orally for 6 d preoperatively and 10 d postoperatively. Outcomes were measured by assessing bacterial translocation, postoperative intestinal permeability, serum zonulin concentrations, duration of postoperative pyrexia, and cumulative duration of antibiotic therapy. The postoperative infection rate, the positive rate of blood microbial DNA, and the incidence of postoperative infectious complications-including septicemia, central line infection, pneumonia, urinary tract infection, and diarrhea-were also assessed. The infection rate was lower in the probiotics group than in the control group (P zonulin concentration (P zonulin concentrations in patients undergoing colectomy. We propose a clinical regulatory model that might explain this association. This trial was registered at http://www.chictr.org/en/ as ChiCTR-TRC-00000423.

A comparative evaluation of the efficacy of probiotic and chlorhexidine mouthrinses on clinical inflammatory parameters of gingivitis: A randomized controlled clinical study

Directory of Open Access Journals (Sweden)

Purnima Vidyesh Nadkerny

2015-01-01

Full Text Available Background: The aim of our clinical trial was to assess and compare the antiplaque and anti-inflammatory potential of a probiotic mouthwash with 0.2% chlorhexidine and saline. Materials and Methods: A randomized parallel group study was designed for a period of 4 weeks on 45 systemically healthy subjects between 20 and 30 years having chronic gingivitis. The study population was divided into three groups. Group A - 15 subjects were advised experimental (probiotic mouthwash. Group B - 15 subjects were advised positive control (chlorhexidine mouthwash and Group C - 15 subjects into a negative control group (normal saline. Oral prophylaxis was done for all groups at baseline. After the proper oral hygiene instructions, all the three groups were instructed to rinse their mouth with 10 ml of their respective mouthrinse, undiluted for 1 min twice daily, 30 min after brushing. Clinical parameters such as plaque index (PI, gingival index (GI, and oral hygiene index simplified (OHI-S were assessed at baseline, 2 weeks and 4 weeks, respectively. Results: At day 28, the PI, GI, and OHI-S were significantly reduced by all treatment modalities ranking probiotic and chlorhexidine is greater than saline. Conclusion: The probiotic mouthrinses tested was effectively used as an adjunct to mechanical plaque control in the prevention of plaque and gingivitis. Thus, the probiotic mouthrinse has a great therapeutic potential.

Prophylactic Probiotics for Preterm Infants

DEFF Research Database (Denmark)

Olsen, Rie; Greisen, Gorm; Schrøder, Morten

2016-01-01

BACKGROUND: Necrotizing enterocolitis (NEC) is a major morbidity and cause of mortality in preterm neonates. Probiotics seem to have a beneficial role in preventing NEC, which is confirmed in meta-analyses of randomized controlled trials (RCTs). We therefore aimed to review and confirm the efficacy...... of probiotics in preterm neonates obtained in observational studies. OBJECTIVE: To assess the effects of prophylactic probiotics in preterm infants. METHODS: A meta-analysis was performed searching PubMed, EMBASE, CENTRAL (the Cochrane Library) and www.clinicaltrials.gov. Reference lists of reviews of RCTs were...... also searched. Included studies were observational studies that enrolled preterm infants probiotics and measured at least one clinical outcome (e.g. NEC, all-cause mortality, sepsis or long-term development scores). Two authors...

Probiotics: an update.

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Vandenplas, Yvan; Huys, Geert; Daube, Georges

2015-01-01

Triggered by the growing knowledge on the link between the intestinal microbiome and human health, the interest in probiotics is ever increasing. The authors aimed to review the recent literature on probiotics, from definitions to clinical benefits, with emphasis on children. Relevant literature from searches of PubMed, CINAHL, and recent consensus statements were reviewed. While a balanced microbiome is related to health, an imbalanced microbiome or dysbiosis is related to many health problems both within the gastro-intestinal tract, such as diarrhea and inflammatory bowel disease, and outside the gastro-intestinal tract such as obesity and allergy. In this context, a strict regulation of probiotics with health claims is urgent, because the vast majority of these products are commercialized as food (supplements), claiming health benefits that are often not substantiated with clinically relevant evidence. The major indications of probiotics are in the area of the prevention and treatment of gastro-intestinal related disorders, but more data has become available on extra-intestinal indications. At least two published randomized controlled trials with the commercialized probiotic product in the claimed indication are a minimal condition before a claim can be sustained. Today, Lactobacillus rhamnosus GG and Saccharomyces boulardii are the best-studied strains. Although adverse effects have sporadically been reported, these probiotics can be considered as safe. Although regulation is improving, more stringent definitions are still required. Evidence of clinical benefit is accumulating, although still missing in many areas. Misuse and use of products that have not been validated constitute potential drawbacks. Copyright © 2014 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Clinical Efficacy Comparison of Saccharomyces Boulardii and Lactic Acid as Probiotics in Acute Pediatric Diarrhea.

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Asmat, Shakila; Shaukat, Fouzia; Asmat, Raheela; Bakhat, Hafiz Faiq Siddique Gul; Asmat, Tauseef M

2018-03-01

To compare the efficacy of Saccharomyces boulardii and lactic acid producing probiotics in addition to usual treatment regimen to cure diarrhea among children (6 months to 5 years of age). Randomized controlled trial. Department of Pediatrics, Sheikh Zayed Hospital, Lahore, from February to July 2015. Children suffering from acute diarrhea were orally administered Saccharomyces boulardii and lactic acid producing probiotics for 5 days. The efficacy of administered probiotics was monitored. Patients were given Saccharomyces boulardii and lactic acid producing probiotics randomly to remove the bias. Two hundred patients randomly selected for trials; out of which, 100 were treated with Saccharomyces boulardii while the other 100 were supplemented with lactic acid concomitantly along with conventional diarrhea treatment. Results indicated that Saccharomyces boulardii treatment group has significantly higher efficacy rate (45%) compared to lactic acid producing probiotics (26%). This study concluded that Saccharomyces boulardii has a better efficacy compared to lactic acid and may be adopted as a probiotic of choice.

Probiotics for preventing acute upper respiratory tract infections.

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Hao, Qiukui; Dong, Bi Rong; Wu, Taixiang

2015-02-03

Probiotics may improve a person's health by regulating their immune function. Some trials have shown that probiotic strains can prevent respiratory infections. Even though the previous version of our review showed benefits of probiotics for acute upper respiratory tract infections (URTIs), several new studies have been published. To assess the effectiveness and safety of probiotics (any specified strain or dose), compared with placebo, in the prevention of acute URTIs in people of all ages, at risk of acute URTIs. We searched CENTRAL (2014, Issue 6), MEDLINE (1950 to July week 3, 2014), EMBASE (1974 to July 2014), Web of Science (1900 to July 2014), the Chinese Biomedical Literature Database, which includes the China Biological Medicine Database (from 1978 to July 2014), the Chinese Medicine Popular Science Literature Database (from 2000 to July 2014) and the Masters Degree Dissertation of Beijing Union Medical College Database (from 1981 to July 2014). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for completed and ongoing trials on 31 July 2014. Randomised controlled trials (RCTs) comparing probiotics with placebo to prevent acute URTIs. Two review authors independently assessed the eligibility and quality of trials, and extracted data using the standard methodological procedures expected by The Cochrane Collaboration. We included 13 RCTs, although we could only extract data to meta-analyse 12 trials, which involved 3720 participants including children, adults (aged around 40 years) and older people. We found that probiotics were better than placebo when measuring the number of participants experiencing episodes of acute URTI (at least one episode: odds ratio (OR) 0.53; 95% confidence interval (CI) 0.37 to 0.76, P value school absence (OR 0.10; 95% CI 0.02 to 0.47, very low quality evidence). Probiotics and placebo were similar when measuring the rate ratio of episodes of acute

Multiple strains probiotics appear to be the most effective probiotics in the prevention of necrotizing enterocolitis and mortality: An updated meta-analysis.

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Chang, Hung-Yang; Chen, Jin-Hua; Chang, Jui-Hsing; Lin, Hung-Chih; Lin, Chien-Yu; Peng, Chun-Chih

2017-01-01

Some oral probiotics have been shown to prevent necrotizing enterocolitis (NEC) and decrease mortality effectively in preterm very low birth weight (PVLBW) infants. However, it is unclear whether a single probiotic or a mixture of probiotics is most effective for the prevention of NEC. A meta-analysis was conducted by reviewing the most up to date literature to investigate whether multiple strains probiotics are more effective than a single strain in reducing NEC and death in PVLBW infants. Relevant studies were identified by searches of the MEDLINE, EMBASE, and Cochrane CENTRAL databases, from 2001 to 2016. The inclusion criteria were randomized controlled trials of any enteral probiotic supplementation that was initiated within the first 7 days and continued for at least 14 days in preterm infants (≤ 34 weeks' gestation) and/or those of a birth weight ≤1500 g. A total of 25 trials (n = 7345 infants) were eligible for inclusion in the meta-analysis using a fixed-effects model. Multiple strains probiotics were associated with a marked reduction in the incidence of NEC, with a pooled OR of 0.36 (95% CI, 0.24-0.53; P probiotic using Lactobacillus species had a borderline effect in reducing NEC (OR of 0.60; 95% CI 0.36-1.0; P = .05), but not mortality. Multiple strains probiotics had a greater effectiveness in reducing mortality and were associated with a pooled OR of 0.58 (95% CI, 0.43-0.79; P = .0006). Trials using single strain of Bifidobacterium species and Saccharomyces boulardii did not reveal any beneficial effects in terms of reducing NEC or mortality. This updated report found that multiple strains probiotics appear to be the most feasible and effective strategy for the prevention of NEC and reduction of mortality in PVLBW neonates. Further clinical trials should focus on which probiotic combinations are most effective.

Review of the role of probiotics in gastrointestinal diseases in adults.

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Sebastián Domingo, Juan José

Probiotics may act as biological agents that modify the intestinal microbiota and certain cytokine profiles, which can lead to an improvement in certain gastrointestinal diseases. To conduct a review of the evidence of the role of probiotics in certain gastrointestinal diseases in adults. Review conducted using appropriate descriptors, filters and limits in the PubMed database (MEDLINE). The MeSH terms used were Probiotics [in the title] AND Gastrointestinal Diseases, with the following limits or filters: Types of study: Systematic Reviews, Meta-Analysis, Guideline, Practice Guideline, Consensus Development Conference (and Consensus Development Conference NIH), Randomized Controlled Trial, Controlled Clinical Trial and Clinical Trial; age: adults (19 or older); language: English and Spanish; in humans, and with at least one abstract. Full texts of all the Systematic Reviews and meta-analyses directly related to the review's objective were obtained, as well as the Randomised Controlled Trials of the studies that were considered relevant and of sufficient quality for this review. Certain probiotics, different for each process, have proven to be effective and beneficial in cases of acute infectious diarrhoea, antibiotic-associated diarrhoea, Clostridium difficile-associated diarrhoea, pouchitis and Helicobacter pylori infection eradication. Although some probiotics have not demonstrated any benefit, there are certain gastrointestinal diseases in which the use of probiotics, true biological agents, can be recommended. Copyright © 2017 Elsevier España, S.L.U., AEEH y AEG. All rights reserved.

Probiotics as Antifungals in Mucosal Candidiasis.

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Matsubara, Victor H; Bandara, H M H N; Mayer, Marcia P A; Samaranayake, Lakshman P

2016-05-01

Candidais an opportunistic pathogen that causes mucosal and deep systemic candidiasis. The emergence of drug resistance and the side effects of currently available antifungals have restricted their use as long-term prophylactic agents for candidal infections. Given this scenario, probiotics have been suggested as a useful alternative for the management of candidiasis. We analyzed the available data on the efficacy of probiotics in candidal colonization of host surfaces. A number of well-controlled studies indicate that probiotics, particularly lactobacilli, suppressCandidagrowth and biofilm development in vitro.A few clinical trials have also shown the beneficial effects of probiotics in reducing oral, vaginal, and enteric colonization byCandida; alleviation of clinical signs and symptoms; and, in some cases, reducing the incidence of invasive fungal infection in critically ill patients. Probiotics may serve in the future as a worthy ally in the battle against chronic mucosal candidal infections. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Probiotics-mediated suppression of cancer.

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So, Stephanie S Y; Wan, Murphy L Y; El-Nezami, Hani

2017-01-01

Probiotics can be used as an adjuvant for cancer prevention or/and treatment through their abilities to modulate intestinal microbiota and host immune response. Although most of the recent reviews have focused on the potential role of probiotics against colon cancer, only few of them include the probiotic effect on extraintestinal cancers. The present review covers the most important findings from the literature published during the past 20 months (from January 2015 to August 2016) regarding the probiotics-mediated suppression of both gastrointestinal and extraintestinal cancers and the underlying mechanisms. A comprehensive literature search in Pubmed, Science direct and Google scholar databases was conducted to locate all relevant articles that investigated the effect of probiotics on prevention/treatment of both gastrointestinal and extraintestinal cancers. Different mechanisms for the beneficial effects of probiotics against cancer were also discussed, mainly via modulation of gut microbiota which thereby influences host metabolism and immunity. Despite laboratory-based studies having demonstrated encouraging outcomes that probiotics possess antitumor effects, the benefits should not be exaggerated before we get more results from human clinical trials. These are very important before the medical community can accept the use of probiotics as an alternative therapy for cancer control.

Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults—Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Lotta K. Stenman

2016-11-01

Discussion: This clinical trial demonstrates that a probiotic product with or without dietary fiber controls body fat mass. B420 and LU + B420 also reduced waist circumference and food intake, whereas LU alone had no effect on the measured outcomes.

The therapeutic effect of probiotics on rheumatoid arthritis: a systematic review and meta-analysis of randomized control trials.

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Mohammed, Abdelrahman Tarek; Khattab, Mohammed; Ahmed, Ali Mahmoud; Turk, Tarek; Sakr, Nora; M Khalil, Adham; Abdelhalim, Mohamed; Sawaf, Bisher; Hirayama, Kenji; Huy, Nguyen Tien

2017-12-01

Rheumatoid arthritis is an autoimmune disease in which probiotics appears to have an immune modulating action along with decreased inflammatory process. Therefore, we aim to investigate the efficacy of probiotics as an adjuvant therapy for rheumatoid arthritis. A comprehensive literature search was performed using nine databases including PubMed and Web of Science. Interesting data was extracted and meta-analyzed. We assessed the risk of bias using Cochrane Collaboration's tool. The protocol was registered in PROSPERO (CRD 42016036769). We found nine studies involving 361 patients who met our eligibility criteria. Our meta-analysis indicated that pro-inflammatory cytokine IL-6 was significantly lower in the probiotics compared with the placebo group (standardized mean difference = - 0.708; 95% confidence interval (CI) - 1.370 to 0.047, P = 0.036). However, there was no difference between probiotics and placebo in disease activity score (mean difference 0.023; 95% CI - 0.584 to 0.631, P = 0.940). Probiotics lowered pro-inflammatory cytokines IL-6 in RA; however, its clinical effect is still unclear. Hence, many high-quality randomized controlled trials (RCTs) are still needed to prove this effect.

The role of probiotics in the prevention and treatment of childhood infectious diarrhea

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Maria Maragkoudaki

2013-10-01

Full Text Available Probiotics are beneficial bacteria that colonize and replicate in the human intestinal tract providing a positive benefit to the host. Several clinical trials support the efficacy of certain probiotics in the prevention and treatment of various diarrheal illnesses. This paper reviews published clinical trials assessing the efficacy of various probiotic species and strains in preventing and treating acute diarrhea in children. The available evidence shows that few probiotic species (mostly Lactobacillus GG and Saccharomyces boulardii are efficacious in decreasing the duration and the severity of acute gastroenteritis, with the most prominent of the reported benefits, the reduction of the duration of diarrhea by approximately 1 day. With regard to the prevention of acute diarrhea in the community and the hospital, there is modest evidence that some probiotic species may be efficacious in preventing community acquired diarrhea (Bifidobacterium lactis, Lactobacillus reuteri, Lactobacillus GG, nosocomial acquired diarrhea (Lactobacillus GG and Clostridium difficile diarrhea (Lactobacillus GG and Saccharomyces boulardii. In conclusion, the available evidence suggests that probiotics are safe when used in healthy children and effective in reducing the duration of acute infectious diarrhea. Further studies are required to assess the efficacy of selected probiotic species and strains at different dosages for different clinical indications and patient groups.

A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infantS (PiPS) trial.

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Costeloe, Kate; Bowler, Ursula; Brocklehurst, Peter; Hardy, Pollyanna; Heal, Paul; Juszczak, Edmund; King, Andy; Panton, Nicola; Stacey, Fiona; Whiley, Angela; Wilks, Mark; Millar, Michael R

2016-08-01

Necrotising enterocolitis (NEC) and late-onset sepsis remain important causes of death and morbidity in preterm babies. Probiotic administration might strengthen intestinal barrier function and provide protection; this is supported by published meta-analyses, but there is a lack of large well-designed trials. To test the use of the probiotic Bifidobacterium breve strain BBG-001 to prevent NEC, late-onset sepsis and death in preterm babies while monitoring probiotic colonisation of participants. Double-blind, randomised, placebo-controlled trial. Recruitment was carried out in 24 hospitals, and the randomisation programme used a minimisation algorithm. Parents, clinicians and outcome assessors were blinded to the allocation. Babies born between 23 and 30 weeks' gestation and randomised within 48 hours of birth. Exclusions included life-threatening or any gastrointestinal malformation detected within 48 hours of birth and no realistic chance of survival. Active intervention: 1 ml of B. breve BBG-001 in one-eighth-strength infant formula Neocate(®) (Nutricia Ltd, Trowbridge, UK), (6.7 × 10(7) to 6.7 × 10(9) colony-forming units) per dose administered enterally. Placebo: 1 ml of one-eighth-strength infant formula Neocate. Started as soon as practicable and continued daily until 36 weeks' postmenstrual age. Primary outcomes were an episode of bloodstream infection, with any organism other than a skin commensal, in any baby between 72 hours and 46 weeks' postmenstrual age; an episode of NEC Bell stage ≥ 2 in any baby; and death before discharge from hospital. Secondary outcomes included stool colonisation with B. breve. In total, 654 babies were allocated to receive probiotic and 661 to receive placebo over 37 months from July 2010. Five babies were withdrawn; 650 babies from the probiotic group and 660 from the placebo group were included in the primary analysis. Baseline characteristics were well balanced. There was no evidence of benefit for the primary

Probiotics, Prebiotics, and Synbiotics for the Treatment and Prevention of Adult Dermatological Diseases.

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Notay, Manisha; Foolad, Negar; Vaughn, Alexandra R; Sivamani, Raja K

2017-12-01

Probiotic, prebiotic, and synbiotic supplementation is becoming more prevalent nowadays. Clinical studies have demonstrated some of the medical benefits of probiotics, prebiotics, and synbiotics within dermatology but an evidence-based review of their effects in adults is needed. The aim of this study was to identify evidence for the use of supplementation with probiotics, prebiotics, or synbiotics for the prevention and treatment of dermatological diseases in adults. We conducted a search of the Ovid MEDLINE, Cochrane Central Register of Controlled trials and EMBASE electronic databases from 1 January 1946 to 11 January 2017. Trials examining supplementation in the treatment of dermatological diseases using oral or topical probiotics, synbiotics, and prebiotics in adults over the age of 18 years were selected. Of 315 articles, 12 met the inclusion criteria. Nutritional supplementation with probiotics and prebiotics was shown to improve atopic dermatitis (AD) symptomatology, quality of life, or clinical severity in six of nine studies. One study in psoriasis was shown to improve inflammatory markers, and one study suggested that probiotics could be used as adjunctive therapy in the treatment of acne. Preliminary studies are optimistic for the use of some strains of probiotics for symptomatic and clinical improvement in AD, and as adjunctive treatment with antibiotics for acne. Further research is necessary to better assess how probiotics and prebiotics may be used within dermatology.

Probiotic supplementation in children with cystic fibrosis-a systematic review.

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Ananthan, Anitha; Balasubramanian, Haribalakrishna; Rao, Shripada; Patole, Sanjay

2016-10-01

Probiotics may benefit in cystic fibrosis (CF) as gut dysbiosis is associated with gastrointestinal symptoms and exacerbation of respiratory symptoms in CF. We conducted a systematic review of randomized controlled trials (RCTs) and non-RCTs of probiotic supplementation in children with CF, using the Cochrane methodology, preferred reporting items for systematic reviews (PRISMA) statement, and meta-analysis of observational studies in epidemiology (MOOSE) guidelines. Primary outcomes were pulmonary exacerbations, duration of hospitalization and antibiotics, and all-cause mortality. Secondary outcomes included gastrointestinal symptoms, markers of gut inflammation, and intestinal microbial balance. A total of nine studies (RCTs, 6, non-RCTs, 3; N = 275) with some methodological weaknesses were included in the review. The pooled estimate showed significant reduction in the rate of pulmonary exacerbation (fixed effects model, two parallel group RCTs and one cross-over trial: relative risk (RR) 0.25, (95 % confidence interval (95 % CI) 0.15,0.41); p probiotic supplementation. Probiotic supplementation significantly improved gastrointestinal symptoms (one RCT, one non-RCT) and gut microbial balance (decreased Proteobacteria, increased Firmicutes, and Bacteroides in one RCT, one non-RCT). Limited low-quality evidence exists on the effects of probiotics in children with CF. Well-designed adequately powered RCTs assessing clinically meaningful outcomes are required to study this important issue. • Gut dysbiosis is frequent in children with cystic fibrosis due to frequent exposure to pathogens and antibiotics. • Probiotics decrease gut dysbiosis and improve gut maturity and function. What is New: • This comprehensive systematic review shows that current evidence on the safety and efficacy of probiotics in children with cystic fibrosis is limited and of low quality. • Well-designed and adequately powered trials assessing clinically important outcomes are

A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

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Valerio Mezzasalma

2016-01-01

Full Text Available Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3. Each group received a daily oral administration of probiotic mixtures (for 60 days F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60 and was maintained quite similar during the follow-up period (t90. Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219.

Multiple strains probiotics appear to be the most effective probiotics in the prevention of necrotizing enterocolitis and mortality: An updated meta-analysis.

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Hung-Yang Chang

Full Text Available Some oral probiotics have been shown to prevent necrotizing enterocolitis (NEC and decrease mortality effectively in preterm very low birth weight (PVLBW infants. However, it is unclear whether a single probiotic or a mixture of probiotics is most effective for the prevention of NEC.A meta-analysis was conducted by reviewing the most up to date literature to investigate whether multiple strains probiotics are more effective than a single strain in reducing NEC and death in PVLBW infants.Relevant studies were identified by searches of the MEDLINE, EMBASE, and Cochrane CENTRAL databases, from 2001 to 2016.The inclusion criteria were randomized controlled trials of any enteral probiotic supplementation that was initiated within the first 7 days and continued for at least 14 days in preterm infants (≤ 34 weeks' gestation and/or those of a birth weight ≤1500 g.A total of 25 trials (n = 7345 infants were eligible for inclusion in the meta-analysis using a fixed-effects model. Multiple strains probiotics were associated with a marked reduction in the incidence of NEC, with a pooled OR of 0.36 (95% CI, 0.24-0.53; P < .00001. Single strain probiotic using Lactobacillus species had a borderline effect in reducing NEC (OR of 0.60; 95% CI 0.36-1.0; P = .05, but not mortality. Multiple strains probiotics had a greater effectiveness in reducing mortality and were associated with a pooled OR of 0.58 (95% CI, 0.43-0.79; P = .0006. Trials using single strain of Bifidobacterium species and Saccharomyces boulardii did not reveal any beneficial effects in terms of reducing NEC or mortality.This updated report found that multiple strains probiotics appear to be the most feasible and effective strategy for the prevention of NEC and reduction of mortality in PVLBW neonates. Further clinical trials should focus on which probiotic combinations are most effective.

Contemporary meta-analysis of short-term probiotic consumption on gastrointestinal transit.

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Miller, Larry E; Zimmermann, Angela K; Ouwehand, Arthur C

2016-06-07

To determine the efficacy of probiotic supplementation on intestinal transit time (ITT) in adults and to identify factors that influence these outcomes. We conducted a systematic review of randomized controlled trials of probiotic supplementation that measured ITT in adults. Study quality was assessed using the Jadad scale. A random effects meta-analysis was performed with standardized mean difference (SMD) of ITT between probiotic and control groups as the primary outcome. Meta-regression and subgroup analyses examined the impact of moderator variables on SMD of ITT. A total of 15 clinical trials with 17 treatment effects representing 675 subjects were included in this analysis. Probiotic supplementation was moderately efficacious in decreasing ITT compared to control, with an SMD of 0.38 (95%CI: 0.23-0.53, P probiotics in subjects with vs without constipation (SMD: 0.57 vs 0.22, P probiotic strains (R (2) = 20%, P probiotics in meta-regression. Medium to large treatment effects were identified with B. lactis HN019 (SMD: 0.67, P probiotic strains yielded negligible reductions in ITT relative to control. Probiotic supplementation is moderately efficacious for reducing ITT in adults. Probiotics were most efficacious in constipated subjects, when evaluated in high-quality studies, and with certain probiotic strains.

Cochrane Commentary: Probiotics For Prevention of Acute Upper Respiratory Infection.

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Quick, Melissa

2015-01-01

Probiotics may improve a person's health by regulating their immune function. Some trials have shown that probiotic strains can prevent respiratory infections. Even though the previous version of our review showed benefits of probiotics for acute upper respiratory tract infections (URTIs), several new studies have been published. To assess the effectiveness and safety of probiotics (any specified strain or dose), compared with placebo, in the prevention of acute URTIs in people of all ages, who are at risk of acute URTIs. We searched CENTRAL (2014, Issue 6), MEDLINE (1950 to July week 3, 2014), EMBASE (1974 to July 2014), Web of Science (1900 to July 2014), the Chinese Biomedical Literature Database, which includes the China Biological Medicine Database (from 1978 to July 2014), the Chinese Medicine Popular Science Literature Database (from 2000 to July 2014) and the Masters Degree Dissertation of Beijing Union Medical College Database (from 1981 to July 2014). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for completed and ongoing trials on 31 July 2014. Randomised controlled trials (RCTs) comparing probiotics with placebo to prevent acute URTIs. Two review authors independently assessed the eligibility and quality of trials, and extracted data using the standard methodological procedures expected by The Cochrane Collaboration. We included 13 RCTs, although we could only extract data to meta-analyze 12 trials, which involved 3720 participants including children, adults (aged around 40 years) and older people. We found that probiotics were better than placebo when measuring the number of participants experiencing episodes of acute URTI [at least one episode: odds ratio (OR): 0.53; 95% CI = 0.37-0.76, P school absence (OR: 0.10; 95% CI = 0.02-0.47, very low quality evidence). Probiotics and placebo were similar when measuring the rate ratio of episodes of acute URTI (rate ratio: 0

The Efficacy of Xylitol, Xylitol-Probiotic and Fluoride Dentifrices in Plaque Reduction and Gingival Inflammation in Children: A Randomised Controlled Clinical Trial.

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Arat Maden, Eda; Altun, Ceyhan; Açikel, Cengizhan

The present prospective, randomised, placebo-controlled, clinical trial was designed to evaluate the clinical effects of a commercially available dentifrice containing fluoride, xylitol or xylitol-probiotic on the decrease of plaque and gingival inflammation in children between 13 and 15 years of age. Forty-eight adolescents were randomly grouped into three groups of n = 16 each: study group A received xylitol (Xyliwhite) toothpaste; study group B received xylitol-probiotic (Periobiotic) toothpaste; and the control group C received fluoride (Colgate Max Fresh) toothpaste. The subjects were instructed to use the dentifrice determined and a modified Bass brushing technique twice a day for two minutes over a 6-week perioed. Clinical evaluation was performed using a gingival index and a plaque index at baseline and at the end of the 6-week period. From day 0 to 42, reductions in the plaque index were statistically significant in all groups, Colgate Max Fresh, PerioBiotic and Xyliwhite (p-values 0.001, 0.001 and 0.035, respectively), but reductions in the gingival index were statistically significant only in the Colgate Max Fresh and PerioBiotic groups (both with p = 0.001), not in the Xyliwhite group (p = 0.116). PerioBiotic toothpaste was found to be better than Xyliwhite and Colgate Max Fresh toothpastes at reducing plaque and gingival scores. However, statistically significant differences with PerioBiotic and Colgate Max Fresh toothpaste were not observed. It was concluded that PerioBiotic was an all-round dentifrice that produced a significant reduction in both gingivitis and plaque.

Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.

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Karbaschian, Zohreh; Mokhtari, Zeinab; Pazouki, Abdolreza; Kabir, Ali; Hedayati, Mahdi; Moghadam, Somayeh Soleymanzadeh; Mirmiran, Parvin; Hekmatdoost, Azita

2018-05-03

Bariatric surgery is known as one of the most effective treatments for sustainable weight loss; however, it may be associated with some complications. This study was designed to examine the effects of probiotic supplementation on some morbidities related to this surgery. This was a placebo-controlled, double-blind, randomized clinical trial on morbid obese patients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass (OAGB-MGB) surgery to a tertiary referral center. Patients were assigned to receive a probiotic supplement (Familact®) or placebo from 4 weeks prior to surgery to 12 weeks after surgery. Anthropometric, biochemical, and inflammatory indices were evaluated at the beginning and the end of the study. At the end of study, significant improvements in some serum inflammatory markers, vitamin D status, and anthropometric measurements were observed (p < 0.05), which were significantly more in probiotic group rather than placebo group (p < 0.05). Moreover, significant improvements in glycemic indices and lipid profile were observed in both groups; however, these changes were not significantly different between the groups. There was no significant difference in serum levels of vitamin B 12 , folate, and homocysteine between groups at week 16 of the study. Our results indicate that probiotic supplementation promotes inflammatory markers, body weight loss, and status of vitamin D in patients undergoing OAGB-MGB bypass. Whether these findings will sustain in longer treatment duration remained to be elucidated in future studies. This study has been registered at Clinicaltrial.gov with registration number NCT02708589.

Probiotic supplements and debridement of peri-implant mucositis

DEFF Research Database (Denmark)

Hallström, Hadar; Lindgren, Susann; Widén, Cecilia

2016-01-01

OBJECTIVE: The aim of this double-blind randomized placebo-controlled trial was to evaluate the effects of probiotic supplements in adjunct to conventional management of peri-implant mucositis. MATERIALS AND METHODS: Forty-nine adult patients with peri-implant mucositis were consecutively recruited...... debridement and oral hygiene reinforcement resulted in clinical improvement of peri-implant mucositis and a reduction in cytokine levels. Probiotic supplements did not provide added benefit to placebo....

Effect of daily consumption of probiotic yoghurt on insulin resistance in pregnant women: a randomized controlled trial.

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Asemi, Z; Samimi, M; Tabassi, Z; Naghibi Rad, M; Rahimi Foroushani, A; Khorammian, H; Esmaillzadeh, A

2013-01-01

Owing to excess body weight and increased secretion of inflammatory cytokines primarily during the third trimester, pregnancy is associated with elevated insulin resistance. To our knowledge, no report is available indicating the effects of probiotic yoghurt consumption on serum insulin levels in pregnant women. This study was designed to determine the effects of daily consumption of probiotic yoghurt on insulin resistance and serum insulin levels of Iranian pregnant women. In this randomized controlled clinical trial, 70 primigravida pregnant women with singleton pregnancy at their third trimester were participated. We randomly assigned participants to consume 200 g per day of conventional (n=33) or the probiotic group (n=37) for 9 weeks. The probiotic yoghurt was a commercially available product prepared with the starter cultures of Streptococcus thermophilus and Lactobacillus bulgaricus, enriched with probiotic culture of two strains of lactobacilli (Lactobacillus acidophilus LA5) and bifidobacteria (Bifidobacterium animalis BB12) with a total of min 1 × 10⁷ colony-forming units. Fasting blood samples were taken at baseline and after 9-week intervention to measure fasting plasma glucose and serum insulin levels. Homeostatic model assessment of insulin resistance (HOMA-IR) was used to calculate insulin resistance score. Although consumption of probiotic yogurt for 9 weeks did not affect serum insulin levels and HOMA-IR score, significant differences were found comparing changes in these variables between probiotic and conventional yogurts (changes from baseline in serum insulin levels: +1.2±1.2 vs +5.0±1.1 μIU/ml, respectively, P=0.02; and in HOMA-IR score: -0.2±0.3 vs 0.7±0.2, respectively, P=0.01). It is concluded that in contrast to conventional yogurt, daily consumption of probiotic yogurt for 9 weeks maintains serum insulin levels and might help pregnant women prevent developing insulin resistance.

Probiotics and necrotizing enterocolitis.

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Fleming, Paul; Hall, Nigel J; Eaton, Simon

2015-12-01

Probiotics for the prevention of necrotizing enterocolitis have attracted a huge interest. Combined data from heterogeneous randomised controlled trials suggest that probiotics may decrease the incidence of NEC. However, the individual studies use a variety of probiotic products, and the group at greatest risk of NEC, i.e., those with a birth weight of less than 1000 g, is relatively under-represented in these trials so we do not have adequate evidence of either efficacy or safety to recommend universal prophylactic administration of probiotics to premature infants. These problems have polarized neonatologists, with some taking the view that it is unethical not to universally administer probiotics to premature infants, whereas others regard the meta-analyses as flawed and that there is insufficient evidence to recommend routine probiotic administration. Another problem is that the mechanism by which probiotics might act is not clear, although some experimental evidence is starting to accumulate. This may allow development of surrogate endpoints of effectiveness, refinement of probiotic regimes, or even development of pharmacological agents that may act through the same mechanism. Hence, although routine probiotic administration is controversial, studies of probiotic effects may ultimately lead us to effective means to prevent this devastating disease.

Strain-Specificity and Disease-Specificity of Probiotic Efficacy: A Systematic Review and Meta-Analysis

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Lynne V. McFarland

2018-05-01

Full Text Available BackgroundAs the use and diversity of probiotic products expands, the choice of an appropriate type of probiotic is challenging for both medical care professionals and the public alike. Two vital factors in choosing the appropriate probiotic are often ignored, namely, the probiotic strain-specificity and disease-specificity for efficacy. Reviews and meta-analyses often pool together different types of probiotics, resulting in misleading conclusions of efficacy.MethodsA systematic review of the literature (1970–2017 assessing strain-specific and disease-specific probiotic efficacy was conducted. Trials were included for probiotics with an identifiable strain (either single strain or mixtures of strains that had at least two randomized, controlled trials for each type of disease indication. The goal was to determine if probiotic strains have strain and/or disease-specific efficacy.ResultsWe included 228 trials and found evidence for both strain specificity and disease specificity for the efficacy of specific probiotic strains. Significant efficacy evidence was found for 7 (70% of probiotic strain(s among four preventive indications and 11 (65% probiotic strain(s among five treatment indications. Strain-specific efficacy for preventing adult antibiotic-associated diarrhea was clearly demonstrated within the Lactobacillus species [e.g., by the mixture of Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R, and Lactobacillus rhamnosus CLR2 (Bio-K+®, by L. casei DN114001 (Actimel® and by Lactobacillus reuteri 55730], while other Lactobacillus strains did not show efficacy. Significant disease-specific variations in efficacy was demonstrated by L. rhamnosus GG and Saccharomyces boulardii CNCM I-745, as well as other probiotic strains.ConclusionStrong evidence was found supporting the hypothesis that the efficacy of probiotics is both strain-specific and disease-specific. Clinical guidelines and meta-analyses need to recognize the

Probiotic guidelines and physician practice: a cross-sectional survey and overview of the literature.

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Draper, K; Ley, C; Parsonnet, J

2017-08-24

Probiotic use by patients and physicians has dramatically increased over the last decade, although definitive evidence is often lacking for their use. We examined probiotic-prescribing practices among health care providers (HCP) at a tertiary medical centre and compared these practices to clinical guidelines. HCP at the Stanford Medical Center received a survey on probiotic prescribing practices including choice of probiotic and primary indications. A broad overview of the literature was performed. Among 2,331 HCP surveyed, 632 responded. Of the 582 of these who routinely prescribed medications, 61% had recommended probiotic foods or supplements to their patients. Women and gastroenterologists were more likely to prescribe probiotics (odds ratio (OR): 1.5, 95% confidence interval (CI): 1.0-2.1; OR: 3.9, 95% CI: 1.5-10.1, respectively). Among probiotic prescribers, 50% prescribed inconsistently or upon patient request, and 40% left probiotic choice to the patient. Common indications for probiotics, particularly Lactobacillus GG, were prevention and treatment of antibiotic-associated diarrhoea (79 and 66%, respectively). Probiotics were often prescribed for 'general bowel health' or at patient request (27 and 39% of responders, respectively). Most respondents (63%) thought an electronic medical record (EMR) pop-up would change probiotic prescribing patterns. However, a review of published guidelines and large trials found inconsistencies in probiotic indications, dosages and strain selection. Probiotic prescribing is common but lacks consistency, with choice of probiotic frequently left to the patient, even for indications with some strain-specific evidence. Implementation of EMR pop-ups/pocket guides may increase consistency in probiotic prescribing, although the lack of clear and consistent guidelines must first be addressed with large, well-designed clinical trials.

Tolerogenic probiotics: potential immunoregulators in Systemic Lupus Erythematosus.

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Esmaeili, Seyed-Alireza; Mahmoudi, Mahmoud; Momtazi, Amir Abbas; Sahebkar, Amirhossein; Doulabi, Hassan; Rastin, Maryam

2017-08-01

Probiotics are commensal or nonpathogenic microbes that colonize the gastrointestinal tract and confer beneficial effects on the host through several mechanisms such as competitive exclusion, anti-bacterial effects, and modulation of immune responses. There is growing evidence supporting the immunomodulatory ability of some probiotics. Several experimental and clinical studies have been shown beneficial effect of some probiotic bacteria, particularly Lactobacillus and Bifidobacteria strains, on inflammatory and autoimmune diseases. Systemic lupus erythematosus (SLE) is an autoimmune disease that is mainly characterized by immune intolerance towards self-antigens. Some immunomodulatory probiotics have been found to regulate immune responses via tolerogenic mechanisms. Dendritic and T regulatory (Treg) cells, IL-6, IFN-γ, IL-17, and IL-23 can be considered as the most determinant dysregulated mediators in tolerogenic status. As demonstrated by documented experimental and clinical trials on inflammatory and autoimmune diseases, a number of probiotic bacterial strains can restore tolerance in host through modification of such dysregulated mediators. Since there are limited reports regarding to impact of probiotic supplementation in SLE patients, the preset review was aimed to suggest a number of probiotics bacteria, mainly from Bifidobacteria and Lactobacillus strains that are able to ameliorate immune responses. The aim was followed through literature survey on immunoregulatory probiotics that can restore tolerance and also modulate the important dysregulated pro/anti-inflammatory cytokines contributing to the pathogenesis of SLE. © 2016 Wiley Periodicals, Inc.

Role of Probiotics in Short Bowel Syndrome in Infants and Children—A Systematic Review

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Shripada Rao

2013-03-01

Full Text Available Short bowel syndrome (SBS is a cause of significant morbidity and mortality in children. Probiotics, due to their beneficial effects on the gastrointestinal tract (e.g., improving gut barrier function, motility, facilitation of intestinal adaptation and decreasing pathogen load and inflammation may have a therapeutic role in the management of SBS. To conduct a systematic review of the current evidence for the effects of probiotic supplementation in children with SBS, the standard Cochrane methodology for systematic reviews was used. The databases, Pubmed, Embase, ACTR, CENTRAL, and the international trial registry, and reference lists of articles were searched for randomised (RCT or quasi-randomised controlled trials reporting on the use of probiotics in SBS. Our search revealed no RCTs on the use of probiotics in children with SBS. We found one small cross-over RCT (placebo controlled crossover clinical trial, one case control study and nine case reports on the use of probiotics in children with SBS. In the crossover RCT, there was no consistent effect on intestinal permeability (primary outcome after supplementation with Lactobacillus rhamnosus (LGG in nine children with SBS. The case control study (four cases: four controls reported a trend for increase in height and weight velocity and improvement in non-clinical outcomes, such as gut flora, lymphocyte count and serum prealbumin. Five of the nine case reports showed that children (n = 12 with SBS were benefited (e.g., cessation of diarrhoea, improved faecal flora, weight gain and weaning from parenteral nutrition by probiotic supplementation. The remaining four reported on the adverse effects, such as Lactobacillus sepsis (n = 3 and d-lactic acidosis (n = 2. There is insufficient evidence on the effects of probiotics in children with SBS. The safety and efficacy of probiotic supplementation in this high-risk cohort needs to be evaluated in large definitive trials.

Effectiveness of probiotics in irritable bowel syndrome: Updated systematic review with meta-analysis

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Didari, Tina; Mozaffari, Shilan; Nikfar, Shekoufeh; Abdollahi, Mohammad

2015-01-01

AIM: To investigate the efficacy of probiotics in irritable bowel syndrome (IBS) patients. METHODS: PubMed, Cochrane library, Scopus, Google Scholar, and Clinicaltrial.gov databases were searched for literature published between September 2007 and December 2013. The applied Mesh terms were “probiotics,” “irritable bowel syndrome,” and “irritable bowel syndrome treatment.” The collected data contained24 clinical trials, of which 15 were eligible for meta-analysis and nine were reviewed systematically. All studies were randomized placebo-controlled trials in patients with IBS that investigated the efficacy of probiotics in IBS improvement. The Jadad score was used to assess the methodological quality of trials. The quality scale ranges from 0 to 5 points, with a score ≤ 2 indicating a low quality report, and a score of ≥ 3 indicating a high quality report. Relative risk (RR), standardized effect size, and 95%CI were calculated using the DerSimonian-Laird method. The Cochran Q test was used to test heterogeneity with P probiotics to placebo was 1.96 (95%CI: 1.14-3.36; P = 0.01). RR of responders to therapies based on a global symptom score in IBS patients for two included trials comparing probiotics with placebo was 2.43 (95%CI: 1.13-5.21; P = 0.02). For adequate improvement of general symptoms in IBS patients, the RR of seven included trials (six studies) comparing probiotics with placebo was 2.14 (95%CI: 1.08-4.26; P = 0.03). Distension, bloating, and flatulence were evaluated using an IBS severity scoring system in three trials (two studies) to compare the effect of probiotic therapy in IBS patients with placebo, the standardized effect size of mean differences for probiotics therapy was -2.57 (95%CI: -13.05--7.92). CONCLUSION: Probiotics reduce pain and symptom severity scores. The results demonstrate the beneficial effects of probiotics in IBS patients in comparison with placebo. PMID:25780308

Probiotics for the Primary and Secondary Prevention of C. difficile Infections: A Meta-analysis and Systematic Review

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Lynne V. McFarland

2015-04-01

Full Text Available Clostridium difficile infections are a global clinical concern and are one of the leading causes of nosocomial outbreaks. Preventing these infections has benefited from multidisciplinary infection control strategies and new antibiotics, but the problem persists. Probiotics are effective in preventing antibiotic-associated diarrhea and may also be a beneficial strategy for C. difficile infections, but randomized controlled trials are scarce. This meta-analysis pools 21 randomized, controlled trials for primary prevention of C. difficile infections (CDI and four trials for secondary prevention of C. difficile recurrences and assesses the efficacy of specific probiotic strains. Four probiotics significantly improved primary CDI prevention: (Saccharomyces boulardii, Lactobacillus casei DN114001, a mixture of L. acidophilus and Bifidobacterium bifidum, and a mixture of L. acidophilus, L. casei and L. rhamnosus. None of the tested probiotics significantly improved secondary prevention of CDI. More confirmatory randomized trials are needed to establish if probiotics are useful for preventing C. difficile infections. v

Beneficial properties of probiotic yeast Saccharomyces boulardii

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Tomičić Zorica M.

2016-01-01

Full Text Available Saccharomyces boulardii is unique probiotic and biotherapeutic yeast, known to survive in gastric acidity and it is not adversely affected or inhibited by antibiotics or does not alter or adversely affect the normal microbiota. S. boulardii has been utilized worldwide as a probiotic supplement to support gastrointestinal health. The multiple mechanisms of action of S. boulardii and its properties may explain its efficacy and beneficial effects in acute and chronic gastrointestinal diseases that have been confirmed by clinical trials. Caution should be taken in patients with risk factors for adverse events. Its potential application in various dairy foods could offer an alternative probiotic product to people suffering from antibiotic-associated diarrhea. This review discusses the evidence for efficacy and safety of S. boulardii as a probiotic for the prevention and therapy of gastrointestinal disorders in humans.

Effects of probiotic yogurt consumption on lipid profile in type 2 diabetic patients: A randomized controlled clinical trial.

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Mohamadshahi, Majid; Veissi, Masoud; Haidari, Fatemeh; Javid, Ahmad Zare; Mohammadi, Fatemeh; Shirbeigi, Esmat

2014-06-01

Alteration in plasma lipid and lipoprotein profile has been documented in diabetic patients. The purpose of this study was to compare the effect of probiotic and conventional yogurt on lipid profile in type 2 diabetes mellitus patients. A total of 44 patients with type 2 diabetes aged 30-60 years old who had low density lipoprotein cholesterol (LDL-c) ≥100 mg/dl enrolled in this randomized, double - blind controlled trial and were assigned to two intervention and control groups. The subjects in the intervention group consumed 300 g/d probiotic yogurt containing Lactobacillus acidophilus La-5 and Bifidobacterium lactis Bb-12 and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks. Anthropometric indices, dietary intake, and serum lipid profile were evaluated at the beginning and end of the intervention. Independent-sample t-test, paired sample t-test, ANCOVA, and repeated measures were used for statistical analysis. The consumption of probiotic yogurt caused significant decrease in LDL-c/high density lipoprotein cholesterol (HDL-c) ratio (3.13 ± 1.00-2.07 ± 0.71, P = 0.016). The levels of HDL-c were increased significantly (43.66 ± 6.80-50.42 ± 6.64, P = 0.023) in the intervention group postintervention. However, there were no significant differences in triglyceride and total cholesterol levels between two groups postintervention (P consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes.

Open Clinical Trial on Using Nifuroxazide Compared to Probiotics in Treating Acute Diarrhoeas in Adults.

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Begovic, Begler; Ahmedtagic, Sead; Calkic, Lejla; Vehabović, Midhat; Kovacevic, Sanela Bakić; Catic, Tarik; Mehic, Meliha

2016-12-01

Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 10 7 live lyophilised lactic-acid bacteria) three times a day for three days. Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study.

Meta-Analysis: Effects of Probiotic Supplementation on Lipid Profiles in Normal to Mildly Hypercholesterolemic Individuals.

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Mikiko Shimizu

Full Text Available Recent experimental and clinical studies have suggested that probiotic supplementation has beneficial effects on serum lipid profiles. However, there are conflicting results on the efficacy of probiotic preparations in reducing serum cholesterol.To evaluate the effects of probiotics on human serum lipid levels, we conducted a meta-analysis of interventional studies.Eligible reports were obtained by searches of electronic databases. We included randomized, controlled clinical trials comparing probiotic supplementation with placebo or no treatment (control. Statistical analysis was performed with Review Manager 5.3.3. Subanalyses were also performed.Eleven of 33 randomized clinical trials retrieved were eligible for inclusion in the meta-analysis. No participant had received any cholesterol-lowering agent. Probiotic interventions (including fermented milk products and probiotics produced changes in total cholesterol (TC (mean difference -0.17 mmol/L, 95% CI: -0.27 to -0.07 mmol/L and low-density lipoprotein cholesterol (LDL-C (mean difference -0.22 mmol/L, 95% CI: -0.30 to -0.13 mmol/L. High-density lipoprotein cholesterol and triglyceride levels did not differ significantly between probiotic and control groups. In subanalysis, long-term (> 4-week probiotic intervention was statistically more effective in decreasing TC and LDL-C than short-term (≤ 4-week intervention. The decreases in TC and LDL-C levels with probiotic intervention were greater in mildly hypercholesterolemic than in normocholesterolemic individuals. Both fermented milk product and probiotic preparations decreased TC and LDL-C levels. Gaio and the Lactobacillus acidophilus strain reduced TC and LDL-C levels to a greater extent than other bacterial strains.In conclusion, this meta-analysis showed that probiotic supplementation could be useful in the primary prevention of hypercholesterolemia and may lead to reductions in risk factors for cardiovascular disease.

Effect of Probiotics on Glucose and Lipid Metabolism in Type 2 Diabetes Mellitus: A Meta-Analysis of 12 Randomized Controlled Trials.

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Yao, Kecheng; Zeng, Linghai; He, Qian; Wang, Wei; Lei, Jiao; Zou, Xiulan

2017-06-22

BACKGROUND It has been unclear whether supplemental probiotics therapy improves clinical outcomes in type 2 diabetic patients. This meta-analysis aimed to summarize the effect of probiotics on glucose and lipid metabolism and C-reactive protein (CRP) from 12 randomized controlled trials (RCTs). MATERIAL AND METHODS An up-to-date search was performed for all relevant RCTs up to April 2016 from PubMed, Embase, and Cochrane Library. Standardized mean difference (SMD) and weighted mean difference (WMD) were calculated for a fixed-effect and random-effect meta-analysis to assess the impact of supplemental probiotics on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), lipid profile, and CRP level. RESULTS A total of 12 studies (684 patients) were entered into the final analysis. The effect of probiotics was significant on reducing HbA1c level (standardized mean difference [SMD], -0.38; confidence interval [CI], -0.62 to -0.14, P=0.002; I²=0%, P=0.72 for heterogeneity), fasting insulin level (SMD, -0.38; CI -0.59 to -0.18, P=0.0003; I²=0%, P=0.81 for heterogeneity), and HOMA-IR (SMD, -0.99; CI -1.52 to -0.47, P=0.0002; I²=86%, Pprobiotics on FPG, CRP, or lipid profile were either non-significant or highly heterogeneous. CONCLUSIONS This meta-analysis demonstrated that probiotics supplementation was associated with significant improvement in HbA1c and fasting insulin in type 2 diabetes patients. More randomized placebo-controlled trials with large sample sizes are warranted to confirm our conclusions.

Probiotics and down-regulation of the allergic response.

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Kalliomäki, Marko A; Isolauri, Erika

2004-11-01

The first clinical trials with probiotics, especially in the treatment of atopic eczema, have yielded encouraging results. Experimental studies have found that probiotics exert strain-specific effects in the intestinal lumen and on epithelial cells and immune cells with anti-allergic potential. These effects include enhancement in antigen degradation and gut barrier function and induction of regulatory and proinflammatory immune responses, the latter of which occurs more likely beyond the intestinal epithelium. Future studies should address more accurately how these and other possible mechanisms operate in the complex gastrointestinal macroenvironment in vivo and how these mechanisms are related to the clinical effects in a dose-dependent manner.

New Approaches for Bacteriotherapy: Prebiotics, New-Generation Probiotics, and Synbiotics

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Patel, Rachna; DuPont, Herbert L.

2015-01-01

The gut microbiota has a significant role in human health and disease. Dysbiosis of the intestinal ecosystem contributes to the development of certain illnesses that can be reversed by favorable alterations by probiotics. The published literature was reviewed to identify scientific data showing a relationship between imbalance of gut bacteria and development of diseases that can be improved by biologic products. The medical conditions vary from infectious and antibiotic-associated diarrhea to obesity to chronic neurologic disorders. A number of controlled clinical trials have been performed to show important biologic effects in a number of these conditions through administration of prebiotics, probiotics, and synbiotics. Controlled clinical trials have identified a limited number of prebiotics, probiotic strains, and synbiotics that favorably prevent or improve the symptoms of various disorders including inflammatory bowel disease, irritable bowel syndrome, infectious and antibiotic-associated diarrhea, diabetes, nonalcoholic fatty liver disease, necrotizing enterocolitis in very low birth weight infants, and hepatic encephalopathy. Studies have shown that probiotics alter gut flora and lead to elaboration of flora metabolites that influence health through 1 of 3 general mechanisms: direct antimicrobial effects, enhancement of mucosal barrier integrity, and immune modulation. Restoring the balance of intestinal flora by introducing probiotics for disease prevention and treatment could be beneficial to human health. It is also clear that significant differences exist between different probiotic species. Metagenomics and metatranscriptomics together with bioinformatics have allowed us to study the cross-talk between the gut microbiota and the host, furthering insight into the next generation of biologic products. PMID:25922396

Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial.

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Indrio, Flavia; Di Mauro, Antonio; Riezzo, Giuseppe; Civardi, Elisa; Intini, Cristina; Corvaglia, Luigi; Ballardini, Elisa; Bisceglia, Massimo; Cinquetti, Mauro; Brazzoduro, Emanuela; Del Vecchio, Antonio; Tafuri, Silvio; Francavilla, Ruggiero

2014-03-01

Infantile colic, gastroesophageal reflux, and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization, feeding changes, use of drugs, parental anxiety, and loss of parental working days with relevant social consequences. To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions. A prospective, multicenter, double-masked, placebo-controlled randomized clinical trial was performed on term newborns (age hospitalizations, visits to a pediatric emergency department for a perceived health emergency, pharmacologic interventions, and loss of parental working days. In total, 589 infants were randomly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days. Prophylactic use of probiotic. Reduction of daily crying time, regurgitation, and constipation during the first 3 months of life. Cost-benefit analysis of the probiotic supplementation. At 3 months of age, the mean duration of crying time (38 vs 71 minutes; P < .01), the mean number of regurgitations per day (2.9 vs 4.6; P < .01), and the mean number of evacuations per day (4.2 vs 3.6; P < .01) for the L reuteri DSM 17938 and placebo groups, respectively, were significantly different. The use of L reuteri DSM 17938 resulted in an estimated mean savings per patient of €88 (US $118.71) for the family and an additional €104 (US $140.30) for the community. Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition. clinicaltrials.gov Identifier: NCT01235884.

Lactobacillus salivarius NK02: a Potent Probiotic for Clinical Application in Mouthwash.

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Sajedinejad, Neda; Paknejad, Mojgan; Houshmand, Behzad; Sharafi, Hakimeh; Jelodar, Reza; Shahbani Zahiri, Hossein; Noghabi, Kambiz Akbari

2017-06-19

A specific strain of naturally occurring oral lactobacilli was isolated and identified based on morphological, biochemical, and 16S rRNA gene sequencing. The phylogenetic affiliation of the isolate confirmed that the NK02 strain had close association with the Lactobacillus salivarius. An effective mouthwash was developed for treatment of periodontitis and suppression of the indicator bacterium Aggregatibacter actinomycetemcomitans which is an obvious pathogen of periodontal disease. The mouthwash containing L. salivarius NK02 was tested at a dose level of 10 8 (colony forming units (CFU) ml -1 ), monitoring over a period of 4 weeks. The study was a randomized double-blind placebo control trial, and the patients were treated in two groups of control and test by using scaling and root planing (SRP) + placebo and scaling and root planing (SRP) + probiotic, respectively. It appeared that the probiotic mouthwash was able to inhibit the bacterial growth on both saliva and sub-gingival crevice and exhibited antibacterial activity against A. actinomycetemcomitans. The results also showed that SRP+ probiotic treatment led to a significant decrease of gingival index (GI) and bleeding on probing (BOP) compared with that of SRP + placebo for the probiotic group. The rate of decrease in pocket depth was displayed in the group with SRP + probiotic treatment equal to 1/2 mm, and probing pocket depth (PPD) value was decreased in the probiotic bacteria treatment group that can explain the decrease in inflammation in gingiva. Our findings suggest that probiotic mouthwash is healthy for daily use as an alternative for maintaining dental and periodontal health.

Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

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Huang, Ruixue; Wang, Ke; Hu, Jianan

2016-08-06

It has been reported that gut probiotics play a major role in the bidirectional communication between the gut and the brain. Probiotics may be essential to people with depression, which remains a global health challenge, as depression is a metabolic brain disorder. However, the efficacy of probiotics for depression is controversial. This study aimed to systematically review the existing evidence on the effect of probiotics-based interventions on depression. Randomized, controlled trials, identified through screening multiple databases and grey literature, were included in the meta-analysis. The meta-analysis was performed using Review Manager 5.3 software using a fixed-effects model. The meta-analysis showed that probiotics significantly decreased the depression scale score (MD (depressive disorder) = -0.30, 95% CI (-0.51--0.09), p = 0.005) in the subjects. Probiotics had an effect on both the healthy population (MD = -0.25, 95% CI (-0.47--0.03), p = 0.03) and patients with major depressive disorder (MDD) (MD = -0.73, 95% CI (-1.37--0.09), p = 0.03). Probiotics had an effect on the population aged under 60 (MD = -0.43, 95% CI (-0.72--0.13), p = 0.005), while it had no effect on people aged over 65 (MD = -0.18, 95% CI (-0.47-0.11), p = 0.22). This is the first systematic review and meta-analysis with the goal of determining the effect of probiotics on depression. We found that probiotics were associated with a significant reduction in depression, underscoring the need for additional research on this potential preventive strategy for depression.

Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial.

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Zeng, Juan; Wang, Chun-Ting; Zhang, Fu-Shen; Qi, Feng; Wang, Shi-Fu; Ma, Shuang; Wu, Tie-Jun; Tian, Hui; Tian, Zhao-Tao; Zhang, Shu-Liu; Qu, Yan; Liu, Lu-Yi; Li, Yuan-Zhong; Cui, Song; Zhao, He-Ling; Du, Quan-Sheng; Ma, Zhuang; Li, Chun-Hua; Li, Yun; Si, Min; Chu, Yu-Feng; Meng, Mei; Ren, Hong-Sheng; Zhang, Ji-Cheng; Jiang, Jin-Jiao; Ding, Min; Wang, Yu-Ping

2016-06-01

To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia (VAP). This was an open-label, randomized, controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were randomized to receive (1) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis (Medilac-S) 0.5 g three times daily through a nasogastric feeding tube plus standard preventive strategies or (2) standard preventive strategies alone, for a maximum of 14 days. The development of VAP was evaluated daily, and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter. The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients (36.4 vs. 50.4 %, respectively; P = 0.031). The mean time to develop VAP was significantly longer in the probiotics group than in the control group (10.4 vs. 7.5 days, respectively; P = 0.022). The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms (PPMOs) was lower in the probiotics group (24 %) than the control group (44 %) (P = 0.004). However, the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups. The administration of probiotics did not result in any improvement in the incidence of clinically suspected VAP, antimicrobial consumption, duration of mechanical ventilation, mortality and length of hospital stay. Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach.

Effect of Probiotic Curd on Salivary pH and Streptococcus mutans: A Double Blind Parallel Randomized Controlled Trial.

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Srivastava, Shivangi; Saha, Sabyasachi; Kumari, Minti; Mohd, Shafaat

2016-02-01

Dairy products like curd seem to be the most natural way to ingest probiotics which can reduce Streptococcus mutans level and also increase salivary pH thereby reducing the dental caries risk. To estimate the role of probiotic curd on salivary pH and Streptococcus mutans count, over a period of 7 days. This double blind parallel randomized clinical trial was conducted at the institution with 60 caries free volunteers belonging to the age group of 20-25 years who were randomly allocated into two groups. Test Group consisted of 30 subjects who consumed 100ml of probiotic curd daily for seven days while an equal numbered Control Group were given 100ml of regular curd for seven days. Saliva samples were assessed at baseline, after ½ hour 1 hour and 7 days of intervention period using pH meter and Mitis Salivarius Bacitracin agar to estimate salivary pH and S. mutans count. Data was statistically analysed using Paired and Unpaired t-test. The study revealed a reduction in salivary pH after ½ hour and 1 hour in both the groups. However after 7 days, normal curd showed a statistically significant (psalivary pH while probiotic curd showed a statistically significant (psalivary pH. Similarly with regard to S. mutans colony counts probiotic curd showed statistically significant reduction (psalivary pH elevation and reduction of salivary S. mutans counts and thus can be exploited for the prevention of enamel demineralization as a long-term remedy keeping in mind its cost effectiveness.

Positive regulatory effects of perioperative probiotic treatment on postoperative liver complications after colorectal liver metastases surgery: a double-center and double-blind randomized clinical trial.

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Liu, Zhihua; Li, Chao; Huang, Meijin; Tong, Chao; Zhang, Xingwei; Wang, Lei; Peng, Hui; Lan, Ping; Zhang, Peng; Huang, Nanqi; Peng, Junsheng; Wu, Xiaojian; Luo, Yanxing; Qin, Huanlong; Kang, Liang; Wang, Jianping

2015-03-20

Colorectal liver metastases (CLM) occur frequently and postoperative intestinal infection is a common complication. Our previous study showed that probiotics could decrease the rate of infectious complications after colectomy for colorectal cancer. To determine the effects of the perioperative administration of probiotics on serum zonulin levels which is a marker of intestinal permeability and the subsequent impact on postoperative infectious complications in patients with CLM. 150 patients with CLM were randomly divided into control group (n = 68) and probiotics group (n = 66). Probiotics and placebo were given orally for 6 days preoperatively and 10 days postoperatively to control group and probiotics group respectively. We used the local resection for metastatic tumor ,while for large tumor, the segmental hepatectomy. Postoperative outcome were recorded. Furthermore, complications in patients with normal intestinal barrier function and the relation with serum zonulin were analyzed to evaluate the impact on the liver barrier dysfunction. The incidence of infectious complications in the probiotics group was lower than control group. Analysis of CLM patients with normal postoperative intestinal barrier function paralleled with the serum zonulin level. And probiotics could also reduce the concentration of serum zonulin (P = 0.004) and plasma endotoxin (P zonulin level, the rate of postoperative septicemia and maintain the liver barrier in patients undergoing CLM surgery. we propose a new model about the regulation of probiotics to liver barrier via clinical regulatory pathway. We recommend the preoperative oral intake of probiotics combined with postoperative continued probiotics treatment in patients who undergo CLM surgery. ChiCTR-TRC- 12002841 . 2012/12/21.

Probiotics as an adjuvant treatment in Helicobacter pylori eradication therapy.

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Zhu, Xin Yan; Liu, Fei

2017-04-01

Over 80% of individuals infected with Helicobacter pylori (H. pylori) are asymptomatic. Increased resistance to antibiotics and decreased compliance to the therapeutic regimens have led to the failure of eradication therapy. Probiotics, with direct and indirect inhibitory effects on H. pylori in both animal models and clinical trials, have recently been used as a supplementary treatment in H. pylori eradication therapy. Probiotics have been considered useful because of the improvements in H. pylori eradication rates and therapy-related side effects although treatment outcomes using probiotics are controversial due to the heterogeneity of species, strains, doses and therapeutic duration of probiotics. Thus, despite the positive role of probiotics, several factors need to be further considered during their applications. Moreover, adverse events of probiotic use need to be noted. Further investigations into the safety of adjuvant probiotics to H. pylori eradication therapy are required. © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Effects of probiotics on biomarkers of oxidative stress and inflammatory factors in petrochemical workers: A randomized, double-blind, placebo-controlled trial

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Ali Akbar Mohammadi

2015-01-01

Full Text Available Background: The aim of the current study was to determine effects of probiotic yoghurt and multispecies probiotic capsule supplementation on biomarkers of oxidative stress and inflammatory factors in petrochemical workers. Methods: This randomized, double-blind, placebo-controlled trial was done among petrochemical workers. Subjects were randomly divided into three groups to receive 100 g/day probiotic yogurt (n = 12 or one probiotic capsule daily (n = 13 or 100 g/day conventional yogurt (n = 10 for 6 weeks. The probiotic yoghurt was containing two strains of Lactobacillus acidophilus and Bifidobacterium lactis with a total of min 1 Χ 10 7 CFU. Multispecies probiotic capsule contains seven probiotic bacteria spices Actobacillus casei 3 Χ 10 3 , L. acidophilus 3 Χ 10 7 , Lactobacillus rhamnosus 7 Χ 10 9 , Lactobacillus bulgaricus 5 Χ 10 8 , Bifidobacterium breve 2 Χ 10 10 , Bifidobacterium longum 1 Χ 10 9 and Streptococcus thermophilus 3 Χ 10 8 CFU/g. Fasting blood samples were obtained at the beginning and end of the trial to quantify biomarkers of oxidative stress and inflammatory factors. Results: Although a significant within-group decrease in plasma protein carbonyl levels was seen in the probiotic capsule group (326.0 ± 308.9 vs. 251.0 ± 176.3 ng/mL, P = 0.02, the changes were similar among the three groups. In addition, significant within-group decreases in plasma iso prostaglandin were observed in the probiotic supplements group (111.9 ± 85.4 vs. 88.0 ± 71.0 pg/mL, P = 0.003 and in the probiotic yogurt group (116.3 ± 93.0 vs. 92.0 ± 66.0 pg/mL, P = 0.02, nevertheless there were no significant change among the three groups. Conclusions: Taken together, consumption of probiotic yogurt or multispecies probiotic capsule had beneficial effects on biomarkers of oxidative stress in petrochemical workers.

Effect of probiotics on glucose metabolism in patients with type 2 diabetes mellitus: A meta-analysis of randomized controlled trials

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Zhang, Qingqing; Wu, Yucheng; Fei, Xiaoqiang

2016-01-01

Objective: Our aim was to investigate the effects of probiotics on glucose metabolism in patients with type 2 diabetes mellitus using a meta-analysis of randomized, controlled trials. Materials and methods: Online databases Embase, Web of Science, and PubMed were searched until August 2014 to identify eligible articles. Finally, 7 trials were included. Results: Probiotic consumption significantly changed fasting plasma glucose (FPG) by −15.92 mg/dL (95% confidence interval [CI], −29.75 ...

An update on probiotics, prebiotics and symbiotics in clinical nutrition.

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Olveira, Gabriel; González-Molero, Inmaculada

2016-11-01

The concept of prebiotics, probiotics, and symbiotics and their use in different situations of daily clinical practice related to clinical nutrition is reviewed, as well as their role in the treatment/prevention of diarrhea (acute, induced by antibiotics, secondary to radiotherapy), inflammatory bowel disease (ulcerative colitis and pouchitis), in colonic health (constipation, irritable bowel), in liver disease (steatosis and minimum encephalopathy), and in intensive care, surgical, and liver transplantation. While their effectiveness for preventing antibiotic-induced diarrhea and pouchitis in ulcerative colitis appears to be shown, additional studies are needed to establish recommendations in most clinical settings. The risk of infection associated to use of probiotics is relatively low; however, there are selected groups of patients in whom they should be used with caution (as jejunum infusion). Copyright © 2016 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial.

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Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-12-18

Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 10 9 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0-6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference -0.001, 95% confidence interval [CI] -0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI -0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI -0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596. © 2017 Joule Inc. or its licensors.

Probiotics for the prevention of allergy: A systematic review and meta-analysis of randomized controlled trials.

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Cuello-Garcia, Carlos A; Brożek, Jan L; Fiocchi, Alessandro; Pawankar, Ruby; Yepes-Nuñez, Juan José; Terracciano, Luigi; Gandhi, Shreyas; Agarwal, Arnav; Zhang, Yuan; Schünemann, Holger J

2015-10-01

Allergic diseases are considered a health burden because of their high and constantly increasing prevalence, high direct and indirect costs, and undesirable effects on quality of life. Probiotics have been suggested as an intervention to prevent allergic diseases. We sought to synthesize the evidence supporting use of probiotics for the prevention of allergies and inform World Allergy Organization guidelines on probiotic use. We performed a systematic review of randomized trials assessing the effects of any probiotic administered to pregnant women, breast-feeding mothers, and/or infants. Of 2403 articles published until December 2014 identified in Cochrane Central Register of Controlled Trials, MEDLINE, and Embase, 29 studies fulfilled a priori specified inclusion criteria for the analyses. Probiotics reduced the risk of eczema when used by women during the last trimester of pregnancy (relative risk [RR], 0.71; 95% CI, 0.60-0.84), when used by breast-feeding mothers (RR, 0.57; 95% CI, 0.47-0.69), or when given to infants (RR, 0.80; 95% CI, 0.68-0.94). Evidence did not support an effect on other allergies, nutrition status, or incidence of adverse effects. The certainty in the evidence according to the Grading of Recommendation Assessment Development and Evaluation approach is low or very low because of the risk of bias, inconsistency and imprecision of results, and indirectness of available research. Probiotics used by pregnant women or breast-feeding mothers and/or given to infants reduced the risk of eczema in infants; however, the certainty in the evidence is low. No effect was observed for the prevention of other allergic conditions. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Clinical Effects of Lactobacillus rhamnosus in Non-Surgical Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Trial With 1-Year Follow-Up.

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Morales, Alicia; Carvajal, Paola; Silva, Nora; Hernandez, Marcela; Godoy, Claudia; Rodriguez, Gonzalo; Cabello, Rodrigo; Garcia-Sesnich, Jocelyn; Hoare, Anilei; Diaz, Patricia I; Gamonal, Jorge

2016-08-01

Probiotics are living microorganisms that provide beneficial effects for the host when administered in proper quantities. The aim of this double-masked placebo-controlled parallel-arm randomized clinical trial is to evaluate the clinical effects of a Lactobacillus rhamnosus SP1-containing probiotic sachet as an adjunct to non-surgical therapy. Twenty-eight systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically at baseline and 3, 6, 9, and 12 months after therapy. Clinical parameters measured included plaque accumulation, bleeding on probing, probing depths (PDs), and clinical attachment loss. Patients received non-surgical therapy, including scaling and root planing (SRP), and were assigned randomly to a test (SRP + probiotic, n = 14) or control (SRP + placebo, n = 14) group. The intake, once a day for 3 months, of an L. rhamnosus SP1 probiotic sachet commenced after the last session of SRP. Both test and control groups showed improvements in clinical parameters at all time points evaluated. However, the test group showed greater reductions in PD than the control. Also, at initial visits and after 1-year follow-up, the test group showed a statistically significant reduction in the number of participants with PD ≥6 mm, indicating a reduced need for surgery, in contrast to the placebo group. The results of this trial indicate that oral administration of L. rhamnosus SP1 resulted in similar clinical improvements compared with SRP alone.

What do Cochrane systematic reviews say about probiotics as preventive interventions?

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Braga, Vinícius Lopes; Rocha, Luana Pompeu Dos Santos; Bernardo, Daniel Damasceno; Cruz, Carolina de Oliveira; Riera, Rachel

2017-01-01

Probiotics have been used for a range of clinical situations and their use is strongly encouraged by the media worldwide. This study identified and summarized all Cochrane systematic reviews about the preventive effects of probiotics in clinical practice. Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp). We included all Cochrane reviews on any probiotics when they were used as preventive interventions and compared with no intervention, placebo or any other pharmacological or non-pharmacological intervention. 17 Cochrane systematic reviews fulfilled our inclusion criteria and were summarized in this report. None of the reviews included in the present study provided high-quality evidence for any outcome. The benefits from use of probiotics included decreased incidence of antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea; decreased incidence of upper respiratory tract infections and duration of episodes; decreased need for antibiotics and absences from school due to colds; and decreased incidence of ventilator-associated pneumonia. Probiotics seem to decrease the incidence of gestational diabetes mellitus, birthweight, risk of vaginal infection and incidence of eczema. Despite the marketing and the benefits associated with probiotics, there is little scientific evidence supporting the use of probiotics. None of the reviews provided any high-quality evidence for prevention of illnesses through use of probiotics. More trials are needed to gain better knowledge of probiotics and to confirm when their use is beneficial and cost-effective.

Effects of probiotic therapy on hepatic encephalopathy in patients with liver cirrhosis: an updated meta-analysis of six randomized controlled trials.

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Xu, Jun; Ma, Rui; Chen, Li-Feng; Zhao, Li-Jun; Chen, Kan; Zhang, Ren-Bing

2014-08-01

Liver cirrhotic patients with hepatic encephalopathy have poor prognosis. Probiotics alter the intestinal microbiota and reduce the production of ammonia. We conducted a meta-analysis about the role of probiotics on liver cirrhotic patients with hepatic encephalopathy. We collected the relevant literatures up to February 21, 2014 from databases of PubMed, EMBASE and the Cochrane Central Register of Controlled Trials. A statistical analysis was conducted by RevMan 5.2 and STATA 12.0 software. Six randomized controlled trials involving 496 liver cirrhotic patients were included. The results showed that probiotic therapy significantly reduced the development of overt hepatic encephalopathy (OR [95% CI]: 0.42 [0.26, 0.70], P=0.0007). However, probiotics did not affect mortality, levels of serum ammonia and constipation (mortality: OR [95% CI]: 0.73 [0.38, 1.41], P=0.35; serum ammonia: WMD [95% CI]: -3.67 [-15.71, 8.37], P=0.55; constipation: OR [95% CI]: 0.67 [0.29, 1.56], P=0.35). Probiotics decrease overt hepatic encephalopathy in patients with liver cirrhosis.

Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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Ruixue Huang

2016-08-01

Full Text Available It has been reported that gut probiotics play a major role in the bidirectional communication between the gut and the brain. Probiotics may be essential to people with depression, which remains a global health challenge, as depression is a metabolic brain disorder. However, the efficacy of probiotics for depression is controversial. This study aimed to systematically review the existing evidence on the effect of probiotics-based interventions on depression. Randomized, controlled trials, identified through screening multiple databases and grey literature, were included in the meta-analysis. The meta-analysis was performed using Review Manager 5.3 software using a fixed-effects model. The meta-analysis showed that probiotics significantly decreased the depression scale score (MD (depressive disorder = −0.30, 95% CI (−0.51–−0.09, p = 0.005 in the subjects. Probiotics had an effect on both the healthy population (MD = −0.25, 95% CI (−0.47–−0.03, p = 0.03 and patients with major depressive disorder (MDD (MD = −0.73, 95% CI (−1.37–−0.09, p = 0.03. Probiotics had an effect on the population aged under 60 (MD = −0.43, 95% CI (−0.72–−0.13, p = 0.005, while it had no effect on people aged over 65 (MD = −0.18, 95% CI (−0.47–0.11, p = 0.22. This is the first systematic review and meta-analysis with the goal of determining the effect of probiotics on depression. We found that probiotics were associated with a significant reduction in depression, underscoring the need for additional research on this potential preventive strategy for depression.

Probiotics are a good choice in remission of inflammatory bowel diseases: A meta analysis and systematic review.

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Ganji-Arjenaki, Mahboube; Rafieian-Kopaei, Mahmoud

2018-03-01

Altered gut bacteria and bacterial metabolic pathways are two important factors in initiation and progression of inflammatory bowel disease (IBD). However, efficacy of probiotics in remission of patients with IBD has not been characterized. This study was performed on the studies that specifically assessed the efficacy of probiotics in attaining clinical response on patients with various types of IBD. The efficacy of variant species of probiotics in different conditions and the influence of study quality in outcomes of randomized controlled trials (RCTs) were also assessed. The RCTs were collected by searching in MEDLINE Web of Science and Google scholar. Then all studies were abstracted in abstraction form and the outcomes were analyzed with fixed-effect and mixed-effect models for assessment of efficacy of variant species of probiotics in subgroups of IBDs. Analysis of 9 trials showed that probiotics had not significant effect on Crohn's disease (CD) (p = 0.07) but analysis of 3 trials in children with IBD revealed a significant advantage (p probiotics in patients with Ulcerative colitis (UC) in different conditions have significant effects (p = 0.007). VSL#3 probiotics in patients with UC had significant effect (p probiotic, prebiotics had significant effect (p = 0.03) only in patients with UC. Combination of Saccharomyces boulardii, Lactobacillus, and VSL#3 probiotics in CD had also a trend for efficiency (p = 0.057). In children with IBD, the combination of Lactobacillus with VSL#3 probiotics had significant effect (p Probiotics are beneficial in IBD, especially the combination ones in UC. © 2017 Wiley Periodicals, Inc.

Use of Probiotics as Prophylaxis for Postoperative Infections

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Peter Mangell

2011-05-01

Full Text Available Postoperative bacterial infections are common despite prophylactic administration of antibiotics. The wide-spread use of antibiotics in patients has contributed to the emergence of multiresistant bacteria. A restricted use of antibiotics must be followed in most clinical situations. In surgical patients there are several reasons for an altered microbial flora in the gut in combination with an altered barrier function leading to an enhanced inflammatory response to surgery. Several experimental and clinical studies have shown that probiotics (mainly lactobacilli may reduce the number of potentially pathogenia bacteria (PPM and restore a deranged barrier function. It is therefore of interest to test if these abilities of probiotics can be utilized in preoperative prophylaxis. These factors may be corrected by perioperative administration of probiotics in addition to antibiotics. Fourteen randomized clinical trials have been presented in which the effect of such regimens has been tested. It seems that in patients undergoing liver transplantation or elective surgery in the upper gastrointestinal tract prophylactic administration of different probiotic strains in combination with different fibers results in a three-fold reduction in postoperative infections. In parallel there seems to be a reduction in postoperative inflammation, although that has not been studied in a systematic way. The use of similar concepts in colorectal surgery has not been successful in reducing postoperative infections. Reasons for this difference are not obvious. It may be that higher doses of probiotics with longer duration are needed to influence microbiota in the lower gastrointestinal tract or that immune function in colorectal patients may not be as important as in transplantation or surgery in the upper gastrointestinal tract. The favorable results for the use of prophylactic probiotics in some settings warrant further controlled studies to elucidate potential

Probiotic Products in Canada with Clinical Evidence: What Can Gastroenterologists Recommend?

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Gregor Reid

2008-01-01

Full Text Available Probiotics, defined as ‘live microorganisms, which when administered in adequate amounts, confer a health benefit on the host’, are finally becoming an option for gastroenterologists in Canada, after being available for many years in Japan, Europe and the United States of America. Unfortunately, Health Canada and the US Food and Drug Administration have not controlled the use of the term ‘probiotic’ or put into place United Nations and World Health Organization guidelines. The net result is that a host of products called ‘probiotics’ are available but are not truly probiotic. The aim of the present review was to discuss the rationale for probiotics in gastroenterology, and specifically examine which products are options for physicians in Canada, and which ones patients might be using. It is hoped that by clarifying what probiotics are, and the strengths and limitations of their use, specialists will be better placed to make recommendations on the role of these products in patient care. In due course, more clinically documented probiotics will emerge, some with therapeutic effects based on a better understanding of disease processes.

New approaches for bacteriotherapy: prebiotics, new-generation probiotics, and synbiotics.

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Patel, Rachna; DuPont, Herbert L

2015-05-15

The gut microbiota has a significant role in human health and disease. Dysbiosis of the intestinal ecosystem contributes to the development of certain illnesses that can be reversed by favorable alterations by probiotics. The published literature was reviewed to identify scientific data showing a relationship between imbalance of gut bacteria and development of diseases that can be improved by biologic products. The medical conditions vary from infectious and antibiotic-associated diarrhea to obesity to chronic neurologic disorders. A number of controlled clinical trials have been performed to show important biologic effects in a number of these conditions through administration of prebiotics, probiotics, and synbiotics. Controlled clinical trials have identified a limited number of prebiotics, probiotic strains, and synbiotics that favorably prevent or improve the symptoms of various disorders including inflammatory bowel disease, irritable bowel syndrome, infectious and antibiotic-associated diarrhea, diabetes, nonalcoholic fatty liver disease, necrotizing enterocolitis in very low birth weight infants, and hepatic encephalopathy. Studies have shown that probiotics alter gut flora and lead to elaboration of flora metabolites that influence health through 1 of 3 general mechanisms: direct antimicrobial effects, enhancement of mucosal barrier integrity, and immune modulation. Restoring the balance of intestinal flora by introducing probiotics for disease prevention and treatment could be beneficial to human health. It is also clear that significant differences exist between different probiotic species. Metagenomics and metatranscriptomics together with bioinformatics have allowed us to study the cross-talk between the gut microbiota and the host, furthering insight into the next generation of biologic products. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions

Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial

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Lamprecht Manfred

2012-09-01

was not influenced, neither by supplementation nor by exercise. Conclusions The probiotic treatment decreased Zonulin in feces, a marker indicating enhanced gut permeability. Moreover, probiotic supplementation beneficially affected TNF-α and exercise induced protein oxidation. These results demonstrate promising benefits for probiotic use in trained men. Clinical trial registry http://www.clinicaltrials.gov, identifier: NCT01474629

Probiotics as a novel treatment for non-alcoholic Fatty liver disease; a systematic review on the current evidences.

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Kelishadi, Roya; Farajian, Sanam; Mirlohi, Maryam

2013-04-01

Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease, with 5-10% of liver having extra fat. Increase in its prevalence in all age groups is linked with obesity and Type II diabetes. The treatment of NAFLD remains controversial. A growing body of evidence suggests a relation between overgrowth of gut microbiota with NAFLD and non-alcoholic steatohepatitis (NASH). The objective of this review is to provide an overview on experimental and clinical studies assessing all positive and negative effects of probiotics. We made a critical appraisal on various types of documents published from 1999 to March 2012 in journals, electronic books, seminars, and symposium contexts including Medline, PubMed, and Cochrane Central Register of Controlled Trials databases. We used the key words: "non-alcoholic fatty liver disease, probiotics, non-alcoholic steatohepatitis, liver disease, and fatty liver". Probiotics, as biological factors, control the gut microbiota and result in its progression. It is in this sense that they are suggestive of a new and a natural way of promoting liver function. Correspondingly, limited evidence suggests that probiotics could be considered as a new way of treatment for NAFLD. Various experimental studies and clinical trials revealed promising effects of probiotics in improving NAFLD; however given the limited experience in this field, generalization of probiotics as treatment of NAFLD needs substantiation through more trials with a larger sample sizes and with longer-term follow up.

[Microbiota in women; clinical applications of probiotics].

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Álvarez-Calatayud, Guillermo; Suárez, Evaristo; Rodríguez, Juan Miguel; Pérez-Moreno, Jimena

2015-07-18

The main function of vaginal microbiota is to protect the mucosa against the colonization and growth of pathogenic microorganisms. This microbiota is modified by hormonal activity. Its maximum concentration and effectiveness occurs during the fertile period, where there is a predominance of lactobacilli. When it is reduced (microbiota dysbiosis) leads to bacterial vaginosis and candida vaginitis which are common diseases in women. Consequently, instillation of lactobacilli in the vagina has beneficial effects on the symptomatology and prognosis of these illnesses. Breast milk is one of the key factors in the development of gut microbiota of the infant. There is an enteric-breast circulation, which is higher at the end of pregnancy and during breastfeeding. This circulation could explain the modulation of the breast microbiota by using probiotics. It could have a positive impact not only for the health of the mother, who would reduce the incidence of mastitis, but also for their infant. The use of probiotics is a hopeful alternative in various gynecological pathologies. However, it's is necessary first some well-designed, randomized trials with standardized methods and with a significant number of patients in order to confirm its benefits and allow us its use in protocols. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Probiotics and Treatment of Vulvovaginal Candidiasis

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somayeh saleki

2018-02-01

Full Text Available Background: Genital infections are among the most common diseases for which women refer to gynecologists. Vulvovaginal candidiasis is the second most common infection among women. Objective: A few studies have been conducted on new therapeutic regimens improving the effectiveness of current medications; accordingly, the present study was conducted to compare the effectiveness of clotrimazole with clotrimazole plus probiotics in the treatment of vulvovaginal candidiasis. Materials and Methods: The present double-blind clinical trial was conducted on 80 women admitted to Shohada hospital in Tehran in 2014. The participants were randomly divided into 2 groups of clotrimazole and clotrimazole plus probiotics. The collected data included the participants’ sociodemographic information and their medical records along with their symptoms and laboratory results before and after the treatment. Finally, the collected data were analyzed using chi-square test, t test, McNemar test and Fisherexact test. Results: The results showed that both treatments (i.e. clotrimazole and clotrimazole plus probiotics are equally effective in the treatment of vulvovaginal candidiasis (P = 0.499. Conclusion: The results of the present study indicated that supplementing clotrimazole with probiotics results in similar effects compared to administering clotrimazole alone in the treatment of vulvovaginal candidiasis.

Role of probiotics and functional foods in health: gut immune stimulation by two probiotic strains and a potential probiotic yoghurt.

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Maldonado Galdeano, Carolina; Novotny Nuñez, Ivanna; Carmuega, Esteban; de Moreno de LeBlanc, Alejandra; Perdigón, Gabriela

2015-01-01

There are numerous reports that show the benefits on the health attributed to the probiotic consumptions. Most of the studies were performed using animal models and only some of them were validated in controlled human trials. The present review is divided in two sections. In the first section we describe how the probiotic microorganisms can interact with the intestinal epithelial cells that are the first line of cell in the mucosal site, focusing in the studies of two probiotic strains: Lactobacillus casei DN-114001 (actually Lactobacillus paracasei CNCMI-1518) and Lactobacillus casei CRL 431. Then we describe same beneficial effects attributed to probiotic administration and the administration of fermented milks containing these microorganisms or potential probiotic yoghurt, principally on the immune system and on the intestinal barrier in different experimental mouse models like enteropathogenic infection, malnutrition, cancer and intestinal inflammation.

A meta-analysis of randomized trials assessing the effects of probiotic preparations on oral candidiasis in the elderly.

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Ai, Ruixue; Wei, Jiao; Ma, Danhua; Jiang, Lu; Dan, Hongxia; Zhou, Yu; Ji, Ning; Zeng, Xin; Chen, Qianming

2017-11-01

Oral candidiasis is the most common fungal infection and can be attributed in part to dysbiosis, an imbalance in the resident oral microflora. Therefore, probiotics, which counter pathogenic microorganisms through competitive, antagonistic, and immunological effects, have been used by some clinicians. To date, the effect of probiotics in preventing oral candidiasis in the elderly is controversial. A systematic review that summarizes and critically appraises the available clinical trials is therefore necessary. Electronic searches were performed using the Pubmed, Embase, and Cochrane databases. Only randomized controlled trials were included. The Mantel-Haenszel test was used to appraise the odds ratio for single studies and an overall combined odds ratio for all studies combined. Three studies matched the inclusion criteria and were homogeneous. The data from one study that estimated candida growth from plaque and saliva were subdivided, thus a total of four studies with 595 people were included. The overall combined odds ratio was 0.54 (95% CI: 0.38-0.77). Three studies provided that active treatment reduced the risk of oral candidiasis more than placebo: Hatakka et al. (OR 0.51, 95% CI 0.26 to 0.97; 192 participants, plaque); Kraft-Bodi et al. (OR 0.46, 95% CI 0.24 to 0.86; 174 participants, palatal); Kraft-Bodi et al. (OR 0.50, 95% CI 0.26 to 0.98; 174 participants, plaque), while one study provided reverse result: Ishikawa et al. (OR 1.24, 95% CI 0.48 to 3.58; 55 participants, saliva). Probiotics have a preventative effect on oral candidiasis in the elderly. Copyright © 2017. Published by Elsevier Ltd.

What do Cochrane systematic reviews say about probiotics as preventive interventions?

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Vinícius Lopes Braga

Full Text Available ABSTRACT BACKGROUND: Probiotics have been used for a range of clinical situations and their use is strongly encouraged by the media worldwide. This study identified and summarized all Cochrane systematic reviews about the preventive effects of probiotics in clinical practice. DESIGN AND SETTING: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM, Universidade Federal de São Paulo (Unifesp. METHODS: We included all Cochrane reviews on any probiotics when they were used as preventive interventions and compared with no intervention, placebo or any other pharmacological or non-pharmacological intervention. RESULTS: 17 Cochrane systematic reviews fulfilled our inclusion criteria and were summarized in this report. None of the reviews included in the present study provided high-quality evidence for any outcome. The benefits from use of probiotics included decreased incidence of antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea; decreased incidence of upper respiratory tract infections and duration of episodes; decreased need for antibiotics and absences from school due to colds; and decreased incidence of ventilator-associated pneumonia. Probiotics seem to decrease the incidence of gestational diabetes mellitus, birthweight, risk of vaginal infection and incidence of eczema. CONCLUSION: Despite the marketing and the benefits associated with probiotics, there is little scientific evidence supporting the use of probiotics. None of the reviews provided any high-quality evidence for prevention of illnesses through use of probiotics. More trials are needed to gain better knowledge of probiotics and to confirm when their use is beneficial and cost-effective.

CREATION PRINCIPLES, MECHANISM OF ACTION AND CLINICAL APPLICATION OF PROBIOTICS

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Kordon T.I

2014-12-01

Full Text Available In the presented review the general data concerning probiotics is considered, i.e. definitions of the term, classification principles, and the core benefits of usage if compared to antibiotics. Are noted The criteria of choice and the characteristics of the main sorts of bacteria used as basic probiotics. Special attention in terms of usage for producing bacteriemic medicines is paid to Bacillus spore-former bacteria, as normal micro-flora exogenous components that do not produce biofilms. Bacillus sporeformer bacteria are also able to produce a wide spectrum of biologically active substances, including antibiotics, lysozyme, proteolytic enzymes, and able to influence the immunological reactivity of macro-organism, therefore stimulating the growth of secretory immunoglobulins`, macrophages`, natural killers` activity. The Subalinum biological features are considered. The basic for Subalinum is genetically modified strain of Bacillus subtillis 2335/105 with a plasmid, containing the gene for alpha-2 human interferon. The characteristics for genetically modified strains of E. coli is given, as being perspective for creating probiotics for effective treatment of diarrhea, caused by enterotoxigenic E.coli and Vibrio cholera. They are proposed for creating recombinant strains of bifidobacteria for atherosclerosis and cardiovascular diseases` treatment and prevention. They are also prospective for making Lactococcus lactis recombinative strain for ulcerative colitis and Crohn's diseases` treatment. The potential dangers of drugs based on living organisms are being discussed. Some of the mechanisms of probiotics influence on the immune system and aspects of clinical application of probiotics for preventing and treating dysbiosis, atopy, intestinal infections of bacterial and viral, cardiovascular, cancer and secondary immunodeficiencies, are highlighted. The research paper contains the possibility of co-using probiotics as vaccination adjuvant.

Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

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Sung Valerie

2012-08-01

Full Text Available Abstract Background Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old ( Methods/Design Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i number of episodes of infant crying/fussing per 24 hours and ii infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months; iii maternal mental health scores, iv family functioning scores, v parent quality adjusted life years scores, and vi intervention cost-effectiveness (at one and six months; and vii infant faecal microbiota diversity, viii infant faecal calprotectin levels and ix Eschericia coli load (at one month only. Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. Discussion An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If

Effect of the probiotic Lactobacillus murinus LbP2 on clinical parameters of dogs with distemper-associated diarrhea.

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Delucchi, Luis; Fraga, Martín; Zunino, Pablo

2017-04-01

The objective of this study was to assess the effect of the probiotic Lactobacillus murinus native strain (LbP2) on general clinical parameters of dogs with distemper-associated diarrhea. Two groups of dogs over 60 d of age with distemper and diarrhea were used in the study, which was done at the Animal Hospital of the Veterinary Faculty of the University of Uruguay, Montevideo, Uruguay. The dogs were treated orally each day for 5 d with the probiotic or with a placebo (vehicle without bacteria). Clinical parameters were assessed and scored according to a system specially designed for this study. Blood parameters were also measured. Administration of the probiotic significantly improved the clinical score of the patients, whereas administration of the placebo did not. Stool output, fecal consistency, mental status, and appetite all improved in the probiotic-treated dogs. These results support previous findings of beneficial effects with the probiotic L. murinus LbP2 in dogs. Thus, combined with other therapeutic measures, probiotic treatment appears to be promising for the management of canine distemper-associated diarrhea.

Preliminary results on clinical effects of probiotic Lactobacillus salivarius LS01 in children affected by atopic dermatitis.

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Niccoli, Antonio A; Artesi, Anna L; Candio, Francesco; Ceccarelli, Sara; Cozzali, Rita; Ferraro, Luigi; Fiumana, Donatella; Mencacci, Manuela; Morlupo, Maurizio; Pazzelli, Paola; Rossi, Laura; Toscano, Marco; Drago, Lorenzo

2014-01-01

The goal of this study was to evaluate the clinical efficacy of an intake of Lactobacillus salivarius LS01 (DSM 22775) for the treatment of atopic dermatitis (AD) in children. AD is an inflammatory and pruritic chronic relapsing skin disorder with multifactorial etiopathology. Some evidence suggests that probiotics may improve AD by modulating the immune system and the composition of intestinal microbiota. A total of 43 patients aged from 0 to 11 years were enrolled in the study (M/F ratio=1:1) and treated with the probiotic strain L. salivarius LS01. Clinical efficacy of probiotic treatment was assessed from baseline by changes in itch index and in the objective SCORAD/SCORAD index. Patients being given probiotic treatment showed a significant improvement in clinical parameters (SCORAD and itch values) from baseline. The reduction in SCORAD and itch index observed after 4 weeks of treatment also persisted after the cessation of probiotic supplementation. L. salivarius LS01 seems to be able to improve the quality of life of children affected by AD and, as a consequence, it may have promising clinical and research implications.

Probiotics in management of hepatic encephalopathy.

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Sharma, Barjesh Chander; Singh, Jatinderpal

2016-12-01

Gut microflora leads to production of ammonia and endotoxins which play important role in the pathogenesis of hepatic encephalopathy (HE). There is relationship between HE and absorption of nitrogenous substances from the intestines. Probiotics play a role in treatment of HE by causing alterations in gut flora by decreasing the counts of pathogen bacteria, intestinal mucosal acidification, decrease in production and absorption of ammonia, alterations in permeability of gut, decreased endotoxin levels and changes in production of short chain fatty acids. Role of gut microbiota using prebiotics, probiotics and synbiotics have been evaluated in the management of minimal hepatic encephalopathy (MHE), overt HE and prevention of HE. Many studies have shown efficacy of probiotics in reduction of blood ammonia levels, treatment of MHE and prevention of HE. However these trials have problems like inclusion of small number of patients, short treatment durations, variability in HE/MHE related outcomes utilized and high bias risk, errors of systematic and random types. Systematic reviews also have shown different results with one systematic review showing clinical benefits whereas another concluded that probiotics do not have any role in treatment of MHE or HE. Also practical questions on optimal dose, ideal combination of organisms, and duration of treatment and persistence of benefits on long term follow-up are still to be clarified. At present, there are no recommendations for use of probiotics in patients with HE.

Design of a multispecies probiotic mixture to prevent infectious complications in critically ill patients.

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Timmerman, Harro M; Niers, Laetitia E M; Ridwan, Ben U; Koning, Catherina J M; Mulder, Linda; Akkermans, Louis M A; Rombouts, Frans M; Rijkers, Ger T

2007-08-01

Although the potential for probiotics is investigated in an increasing variety of diseases, there is little or no consensus regarding the desired probiotic properties for a particular disease in question, nor about the final design of the probiotic. Specific strain selection procedures were undertaken to design a disease-specific multispecies probiotic. From a strain collection of 69 different lactic acid bacteria a primary selection was made of 14 strains belonging to different species showing superior survival in a simulated gastrointestinal environment. Functional tests like antimicrobial activity against a range of clinical isolates and cytokine inducing capacity in cultured human peripheral blood mononuclear cells were used to further identify potential strains. Specific strains inhibited growth of clinical isolates whereas others superiorly induced the anti-inflammatory cytokine IL-10. Based on functional tests and general criteria regarding probiotic design and safety, a selection of the following six strains was made (Ecologic 641); Bifidobacterium bifidum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus salivarius and Lactococcus lactis. Combination of these strains resulted in a wider antimicrobial spectrum, superior induction of IL-10 and silencing of pro-inflammatory cytokines as compared to the individual components. Application of strict criteria during the design of a disease-specific probiotic prior to implementation in clinical trials may provide a rational basis for use of probiotics.

Probiotics in dermatologic practice.

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Fuchs-Tarlovsky, Vanessa; Marquez-Barba, María Fernanda; Sriram, Krishnan

2016-03-01

Probiotics are live microorganisms that beneficially affect the host when administered in adequate amounts. They have an excellent safety profile. Probiotics have been used as immunomodulators in inflammatory skin conditions, such as atopic dermatitis. The aim of this study was to summarize the available evidence concerning the use of different strains of probiotics in dermatology practice. We conducted a literature review of English and Spanish publications listed in standard databases (PubMed, Ovid, Google Scholar, Medline, and EBSCO), between 1994 and 2015 using the words "probiotics" and "dermatology." We found ∼70 studies containing these criteria and selected 42 in which probiotics were used for dermatologic purposes. We found enough evidence to recommend the use of probiotics in specific conditions in dermatology practice, especially in children with atopic dermatitis. Further well-designed, large population based trials are needed to validate the use of probiotics in dermatology practice, including innovative therapies to rebuild skin barrier defects, protection against microbial colonization, and restoration of immunologic balance. Copyright © 2016 Elsevier Inc. All rights reserved.

Therapeutic Use of Prebiotics, Probiotics, and Postbiotics to Prevent Necrotizing Enterocolitis: What is the Current Evidence?

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Patel, Ravi Mangal; Denning, Patricia Wei

2013-01-01

Synopsis Necrotizing enterocolitis (NEC) is a leading cause of neonatal morbidity and mortality and preventative therapies that are both effective and safe are urgently needed. Current evidence from therapeutic trials suggests that probiotics are effective in decreasing NEC in preterm infants and probiotics are currently the most promising therapy on the horizon for this devastating disease. However, concerns regarding safety and optimal dosing have limited the widespread adoption of routine clinical use of probiotics in preterm infants. In addition, prebiotics and postbiotics may be potential alternatives or adjunctive therapies to the administration of live microorganisms, although studies demonstrating their clinical efficacy in preventing NEC are lacking. This review summarizes the current evidence regarding the use of probiotics, prebiotics and postbiotics in the preterm infant, including its therapeutic role in preventing NEC. PMID:23415261

Effect of probiotics on respiratory, gastrointestinal and nutritional outcomes in patients with cystic fibrosis: A systematic review.

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Anderson, Jacqueline L; Miles, Caitlin; Tierney, Audrey C

2017-03-01

An increasing body of research investigating the use of probiotics to improve health outcomes in patients with cystic fibrosis (CF) prompted the need to systematically assess and summarise the relevant literature. An electronic search of five databases and three trial databases was conducted. Studies describing the administration of probiotics to patients with CF older than 2years, with a comparator group on respiratory, gastrointestinal and nutritional outcomes were included. Three pre-post studies and six randomised controlled trials met the inclusion criteria. Overall studies showed a positive effect of probiotics on reducing the number of pulmonary exacerbations and decreasing gastrointestinal inflammation. There was limited effect of probiotics on other outcomes and inadequate evidence for the effects of specific probiotic species and strains. The findings suggest that probiotics may improve respiratory and gastrointestinal outcomes in a stable CF clinic population with no reported evidence of harm. There is inadequate evidence at this time to recommend a specific species, strain or dose of probiotic as likely to be of significant benefit. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Clinical effect of probiotics in treatment of liver cirrhosis: a Meta-analysis

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SUN Yuanpei

2018-01-01

Full Text Available Objective To investigate the clinical effect of probiotics in the treatment of liver cirrhosis through a systematic review. Methods PubMed, Embase, Cochrane Library, Chinese Scientific Journal Full-Text Database, VIP, and Wanfang Data were searched for randomized controlled trials (RCTs of probiotics for the treatment of liver cirrhosis. RevMan 5.3 software was used for the meta-analysis of the articles screened out. Rate difference (RD and its 95% confidence interval (95% CI were used as effect size indicators for binary variables; weighted mean difference (WMD was used for evaluating continuous variables with the same unit, and standardized mean difference (SMD and its 95% CI were used for evaluating continuous variables with different units. Funnel plots were used to analyze publication bias. Results A total of 15 RCTs which met the inclusion criteria were included, and there were 1411 patients with liver cirrhosis in total (726 in treatment group and 685 in control group. Compared with the control group, the treatment group had significant improvements in overall response rate (RD=0.28, 95%CI：0.22-0.34, P＜0.001 and biochemical parameters for liver function including alanine aminotransferase (SMD=-0.90, 95%CI：-1.14 to -0.66, P＜0.001, total bilirubin (WMD=-15.99, 95%CI：-26.42 to -5.57, P＜0.001, albumin (SMD=0.66, 95%CI：0.40-0.93, P＜0.001, endotoxin (SMD=-1.13, 95%CI：-2.11 to -0.15, P＜0001, and blood ammonia (WMD=-15.86, 95%CI：-21.54 to -10.18, P＜0.001. Conclusion Probiotics can significantly improve liver function in patients with liver cirrhosis, effectively inhibit the progression of liver cirrhosis, reduce the risk of complications including hepatic encephalopathy, and increase overall response rate and have good tolerability.

Gut microbiota and bacterial translocation in digestive surgery: the impact of probiotics.

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Komatsu, Shunichiro; Yokoyama, Yukihiro; Nagino, Masato

2017-05-01

It is conceivable that manipulation of the gut microbiota could reduce the incidence or magnitude of surgical complications in digestive surgery. However, the evidence remains inconclusive, although much effort has been devoted to randomized controlled trials (RCTs) and meta-analyses on probiotics. Furthermore, the mechanism behind the protective effects of probiotics appears elusive, our understanding of probiotic actions being fragmentary. The objective of this review is to assess the clinical relevance of the perioperative use of probiotics in major digestive surgery, based on a comprehensive view of the gut microbiota, bacterial translocation (BT), and host defense system. The first part of this article describes the pathophysiological events associated with the gut microbiota. Results of RCTs for the perioperative use of probiotics in major digestive surgery are reviewed in the latter part. The development of the structural and functional barrier to protect against BT primarily results from the generally cooperative interactions between the host and resident microbiota. There is a large body of evidence indicating that probiotics, by enhancing beneficial interactions, reinforce the host defense system to limit BT. The perioperative use of probiotics in patients undergoing hepatobiliary and pancreatic surgery is a promising approach for the prevention of postoperative infectious complications, while the effectiveness in colorectal surgery remains controversial due to substantial heterogeneity among the RCTs with small sample populations. Further studies, such as multi-center RCTs with a larger sample size, are necessary to confirm the clinical relevance of probiotic agents in major digestive surgery.

Probiotics in colorectal cancer (CRC) with emphasis on mechanisms of action and current perspectives.

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Kahouli, Imen; Tomaro-Duchesneau, Catherine; Prakash, Satya

2013-08-01

Colorectal cancer (CRC) is the third most common form of cancer. Diverse therapies such as chemotherapy, immunotherapy and radiation have shown beneficial effects, but are limited because of their safety and toxicity. Probiotic formulations have shown great promise in CRC as preventive and early stage therapeutics. This review highlights the importance of a balanced intestinal microbiota and summarizes the recent developments in probiotics for treating CRC. Specifically, this report describes evidence of the role of probiotics in modulating the microbiota, in improving the physico-chemical conditions of the gut and in reducing oxidative stress. It also discusses the mechanisms of probiotics in inhibiting tumour progression, in producing anticancer compounds and in modulating the host immune response. Even though some of these effects were observed in several clinical trials, when probiotic formulations were used as a supplement to CRC therapies, the application of probiotics as biotherapeutics against CRC still needs further investigation.

Effects of Probiotic Supplementation on Metabolic Status in Pregnant Women: a Randomized, Double-blind, Placebo-Controlled Trial.

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Jamilian, Mehri; Bahmani, Fereshteh; Vahedpoor, Zahra; Salmani, Ali; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Hashemi Dizaji, Shahrzad; Asemi, Zatollah

2016-10-01

Limited data is available on the effects of multispecies probiotic supplementation on metabolic status in pregnant women in the first half of pregnancy. The current study was carried out to determine the effects of multispecies probiotic capsule supplementation on metabolic status among pregnant women in the first half of pregnancy. A randomized clinical trial was conducted among 60 pregnant women aged 18-37 years. The participants were randomly divided into two groups: group A (n = 30) received multispecies probiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum (2 × 109 CFU/g each) and group B (n = 30) received placebo from 9 weeks of gestation for a duration of 12 weeks. Fasting blood samples were taken at the beginning of the study and after 12 weeks of intervention to determine metabolic profiles, inflammatory cytokines and biomarkers of oxidative stress. After 12 weeks of intervention, compared to the placebo group, the pregnant women who consumed probiotic capsule had significantly decreased serum insulin concentrations (-1.5 ± 4.8 vs. +1.3 ± 5.2 µIU/mL, P = 0.03), the homeostasis model of assessment-estimated insulin resistance (HOMA-IR) (-0.3 ± 0.9 vs. +0.3 ± 1.1, P = 0.04), the homeostasis model of assessment-estimated b cell function (HOMA-B) (-7.2 ± 23.1 vs. +5.3 ± 22.6, P = 0.03) and increased quantitative insulin sensitivity check index (QUICKI) (+0.01 ± 0.05 vs. -0.01 ± 0.02, P = 0.03). In addition, changes in serum triglycerides levels (-14.7 ± 46.5 vs. +37.3 ± 74.2 mg/dL, P = 0.002), high-sensitivity C-reactive protein (hs-CRP) (-1.0 ± 2.6 vs. +1.7 ± 4.3 mg/L, P = 0.004), plasma nitric oxide (NO) (+6.8 ± 9.3 vs. -4.7 ± 7.4 µmol/L, P pregnant women in the first half of pregnancy had beneficial effects on markers of insulin metabolism, triglycerides, biomarkers of inflammation and oxidative stress.

What is the evidence for the use of probiotics in functional disorders?

LENUS (Irish Health Repository)

Quigley, Eamonn M M

2012-02-03

A rationale for the use of probiotics for a number of functional gastrointestinal symptoms and syndromes can be developed, and an experimental basis for their use continues to emerge, but data from well-conducted clinical trials of probiotics in this area remain scarce. Irritable bowel syndrome (IBS) has attracted the most attention; recent revelations regarding the potential pathogenic roles of the enteric flora and immune activation have led to reawakened interest in bacterio-therapy for this common and challenging disorder. Some recent randomized, controlled studies attest to the efficacy of some probiotics in alleviating individual IBS symptoms, and selected strains have a more global impact. Evidence for long-term efficacy is also beginning to emerge, though more studies are needed in this regard. In other functional syndromes, data are far from adequate to make recommendations, but there is evidence for efficacy of probiotics in treating individual symptoms such as diarrhea, constipation, and bloating. The interpretation of much of the literature in this area is complicated by lack of quality control, use of many different species and strains, and, above all, significant deficiencies in trial methodology.

Probiotics and prebiotics: prospects for public health and nutritional recommendations.

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Sanders, Mary Ellen; Lenoir-Wijnkoop, Irene; Salminen, Seppo; Merenstein, Daniel J; Gibson, Glenn R; Petschow, Bryon W; Nieuwdorp, Max; Tancredi, Daniel J; Cifelli, Christopher J; Jacques, Paul; Pot, Bruno

2014-02-01

Probiotics and prebiotics are useful interventions for improving human health through direct or indirect effects on the colonizing microbiota. However, translation of these research findings into nutritional recommendations and public health policy endorsements has not been achieved in a manner consistent with the strength of the evidence. More progress has been made with clinical recommendations. Conclusions include that beneficial cultures, including probiotics and live cultures in fermented foods, can contribute towards the health of the general population; prebiotics, in part due to their function as a special type of soluble fiber, can contribute to the health of the general population; and a number of challenges must be addressed in order to fully realize probiotic and prebiotic benefits, including the need for greater awareness of the accumulated evidence on probiotics and prebiotics among policy makers, strategies to cope with regulatory roadblocks to research, and high-quality human trials that address outstanding research questions in the field. © 2014 New York Academy of Sciences.

Probiotics for prevention of recurrent urinary tract infections in women: a review of the evidence from microbiological and clinical studies.

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Falagas, Matthew E; Betsi, Gregoria I; Tokas, Theodoros; Athanasiou, Stavros

2006-01-01

Recurrent urinary tract infections (UTIs) afflict a great number of women around the world. The use of probiotics, especially lactobacilli, has been considered for the prevention of UTIs. Since lactobacilli dominate the urogenital flora of healthy premenopausal women, it has been suggested that restoration of the urogenital flora, which is dominated by uropathogens, with lactobacilli may protect against UTIs. This review is based on a search of PubMed for relevant articles. Many in vitro studies, animal experiments, microbiological studies in healthy women, and clinical trials in women with UTIs have been carried out to assess the effectiveness and safety of probiotics for prophylaxis against uropathogens. Most of them had encouraging findings for some specific strains of lactobacilli. Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 (previously called L. fermentum RC-14) seemed to be the most effective among the studied lactobacilli for the prevention of UTIs. L. casei shirota and L. crispatus CTV-05 have also shown efficacy in some studies. L. rhamnosus GG did not appear to be quite as effective in the prevention of UTIs. The evidence from the available studies suggests that probiotics can be beneficial for preventing recurrent UTIs in women; they also have a good safety profile. However, further research is needed to confirm these results before the widespread use of probiotics for this indication can be recommended.

Effect of supplements: Probiotics and probiotic plus honey on blood cell counts and serum IgA in patients receiving pelvic radiotherapy

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Hajar-Alsadat Mansouri-Tehrani

2015-01-01

Full Text Available Background: Radiotherapy is frequently used in treatment approaches of pelvic malignancies. Nevertheless, it has some known systemic effects on blood cells and the immune system that possibly results in their susceptibility to infection. Probiotics are live microbial food ingredients that provide a health advantage to the consumer. Honey has prebiotic properties. The aim of this clinical trial was to investigate probable effects of probiotic or probiotics plus honey on blood cell counts and serum IgA levels in patients receiving pelvic radiotherapy. Materials and Methods: Sixty-seven adult patients with pelvic cancer were enrolled. Patients were randomized to receive either: (1 Probiotic capsules (including: Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, and Streptococcus thermophiles (n = 22, (2 probiotic capsules plus honey (n = 21 or (3 placebo capsules (n = 24 all for 6 weeks. Blood and serum samples were collected for one week before radiotherapy and 24-72 h after the end of radiotherapy. Results: White blood cells (WBC, red blood cells (RBC, platelet counts, and serum IgA level were not significantly changed in patients taking probiotic (alone or plus honey during pelvic radiotherapy. The mean decrease in RBC count was 0.52, 0.18, and 0.23 × 10 6 cells/μL, WBC count was 2.3, 1.21, and 1.34 × 10 3 cells/μL and platelet count was, 57.6, 53.3, and 66.35 × 10 3 cells/μL for the probiotic, probiotic plus honey, and placebo groups, respectively. The mean decrease of serum IgA was 22.53, 29.94, and 40.73 mg/dL for the probiotic, probiotic plus honey, and placebo groups, respectively. Conclusion: The observed nonsignificant effect of probiotics may be in favor of local effects of this product in the gut rather than systemic effects, however, as a trend toward a benefit was indicated, further studies are necessary in order to extract effects of

Effect of supplements: Probiotics and probiotic plus honey on blood cell counts and serum IgA in patients receiving pelvic radiotherapy.

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Mansouri-Tehrani, Hajar-Alsadat; Rabbani-Khorasgani, Mohammad; Hosseini, Sayyed Mohsen; Mokarian, Fariborz; Mahdavi, Hoda; Roayaei, Mahnaz

2015-07-01

Radiotherapy is frequently used in treatment approaches of pelvic malignancies. Nevertheless, it has some known systemic effects on blood cells and the immune system that possibly results in their susceptibility to infection. Probiotics are live microbial food ingredients that provide a health advantage to the consumer. Honey has prebiotic properties. The aim of this clinical trial was to investigate probable effects of probiotic or probiotics plus honey on blood cell counts and serum IgA levels in patients receiving pelvic radiotherapy. Sixty-seven adult patients with pelvic cancer were enrolled. Patients were randomized to receive either: (1) Probiotic capsules (including: Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, and Streptococcus thermophiles) (n = 22), (2) probiotic capsules plus honey (n = 21) or (3) placebo capsules (n = 24) all for 6 weeks. Blood and serum samples were collected for one week before radiotherapy and 24-72 h after the end of radiotherapy. White blood cells (WBC), red blood cells (RBC), platelet counts, and serum IgA level were not significantly changed in patients taking probiotic (alone or plus honey) during pelvic radiotherapy. The mean decrease in RBC count was 0.52, 0.18, and 0.23 × 10(6) cells/μL, WBC count was 2.3, 1.21, and 1.34 × 10(3) cells/μL and platelet count was, 57.6, 53.3, and 66.35 × 10(3) cells/μL for the probiotic, probiotic plus honey, and placebo groups, respectively. The mean decrease of serum IgA was 22.53, 29.94, and 40.73 mg/dL for the probiotic, probiotic plus honey, and placebo groups, respectively. The observed nonsignificant effect of probiotics may be in favor of local effects of this product in the gut rather than systemic effects, however, as a trend toward a benefit was indicated, further studies are necessary in order to extract effects of probiotics or probiotic plus honey on hematologic and

Involving seldom-heard groups in a PPI process to inform the design of a proposed trial on the use of probiotics to prevent preterm birth: a case study.

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Rayment, Juliet; Lanlehin, Rosemary; McCourt, Christine; Husain, Shahid M

2017-01-01

When designing clinical trials it is important to involve members of the public, who can provide a view on what may encourage or prevent people participating and on what matters to them. This is known as Public and Patient Involvement (PPI). People from minority ethnic groups are often less likely to take part in clinical trials, but it is important to ensure they are able to participate fully so that health research and its findings are relevant to a wide population. We are preparing to conduct a randomised controlled trial (RCT) to test whether taking probiotic capsules can play a role in preventing preterm birth. Women from some minority ethnic groups, for example women from West Africa, and those who are from low-income groups are more likely to suffer preterm births. Preterm birth can lead to extra costs to health services and psychosocial costs for families. In this article we describe how we engaged women in discussion about the design of the planned trial, and how we aim to use our findings to ensure the trial is workable and beneficial to women, as well as to further engage service users in the future development of the trial. Four socially and ethnically diverse groups of women in East London took part in discussions about the trial and contributed their ideas and concerns. These discussions have helped to inform and improve the design of a small practice or 'pilot' trial to test the recruitment in a 'real life' setting, as well as encourage further PPI involvement for the future full-scale trial. Background Patient and public involvement (PPI) is an important tool in approaching research challenges. However, involvement of socially and ethnically diverse populations remains limited and practitioners need effective methods of involving a broad section of the population in planning and designing research. Methods In preparation for the development of a pilot randomised controlled trial (RCT) on the use of probiotics to prevent preterm birth, we conducted a

The effects of probiotics on total cholesterol

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Wang, Lang; Guo, Mao-Juan; Gao, Qing; Yang, Jin-Feng; Yang, Lin; Pang, Xiao-Li; Jiang, Xi-Juan

2018-01-01

Abstract Background: Probiotics supplements provide a new nonpharmacological alternative to reduce cardiovascular risk factors. The impact of probiotics on the reduction of total cholesterol (TC) remains controversial. We conducted a meta-analysis to showcase the most updated and comprehensive evaluation of the studies. Methods: Randomized controlled trials (RCTs) were searched from electronic databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang database dating from January 2007 to January 2017. The curative effects of probiotics on the reduction of TC were assessed using mean difference (MD), as well as their 95% confidence interval (CI). RevMan software (version 5.3) was used to carry out this meta-analysis. Results: Thirty-two RCTs including 1971 patients met the inclusion criteria. Results of this analysis showed that compared with the control group serum TC was significantly reduced in probiotics group [MD = −13.27, 95% CI (−16.74 to 9.80), P  6 weeks: [MD = −22.18, 95% CI (−28.73, −15.63), P probiotics forms and intervention duration might have a significant impact on the results. However, strains and doses of probiotics had no significant influence on curative effects. Conclusion: Available evidence indicates that probiotics supplements can significantly reduce serum TC. Furthermore, higher baseline TC, longer intervention time, and probiotics in capsules form might contribute to a better curative effect. PMID:29384846

Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial.

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Merenstein, D; Murphy, M; Fokar, A; Hernandez, R K; Park, H; Nsouli, H; Sanders, M E; Davis, B A; Niborski, V; Tondu, F; Shara, N M

2010-07-01

To evaluate whether a fermented dairy drink containing the probiotic strain Lactobacillus casei DN-114 001 could reduce the incidence of common infectious diseases (CIDs) and the change of behavior because of illness in children. We conducted a double-blinded, randomized, placebo-controlled allocation concealment clinical trial in the Washington, DC metropolitan area. Participants were 638 children 3-6 years old in daycare/schools. The intervention was a fermented dairy drink containing a specific probiotic strain or matching placebo with no live cultures for 90 consecutive days. Two primary outcomes were assessed: incidence of CIDs and change of behavior because of illness (both assessed by parental report). The rate of change of behavior because of illness was similar among active and control groups. However, the incidence rate for CIDs in the active group (0.0782) is 19% lower than that of the control group (0.0986) (incidence rate ratio=0.81, 95% CI: 0.65, 099) P=0.046. Daily intake of a fermented dairy drink containing the probiotic strain L. casei DN-114 001 showed some promise in reducing overall incidence of illness, but was primarily driven by gastrointestinal infections and there were no differences in change of behavior.

Mismatch between Probiotic Benefits in Trials versus Food Products

OpenAIRE

Scourboutakos, Mary J.; Franco-Arellano, Beatriz; Murphy, Sarah A.; Norsen, Sheida; Comelli, Elena M.; L?Abb?, Mary R.

2017-01-01

Probiotic food products contain a variety of different bacterial strains and may offer different health effects. The objective was to document the prevalence and dosage of probiotic strains in the Canadian food supply and to review the literature investigating these strains in order to understand what health benefits these products may offer. The Food Label Information Program was used to identify probiotic-containing products in the food supply. PubMed, Web of Science, and Embase were search...

The effect of perioperative probiotics treatment for colorectal cancer: short-term outcomes of a randomized controlled trial.

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Yang, Yongzhi; Xia, Yang; Chen, Hongqi; Hong, Leiming; Feng, Junlan; Yang, Jun; Yang, Zhe; Shi, Chenzhang; Wu, Wen; Gao, Renyuan; Wei, Qing; Qin, Huanlong; Ma, Yanlei

2016-02-16

This study was designed to mainly evaluate the anti-infective effects of perioperative probiotic treatment in patients receiving confined colorectal cancer (CRC) respective surgery. From November 2011 to September 2012, a total of 60 patients diagnosed with CRC were randomly assigned to receive probiotic (n = 30) or placebo (n = 30) treatment. The operative and post-operative clinical results including intestinal cleanliness, days to first - flatus, defecation, fluid diet, solid diet, duration of pyrexia, average heart rate, length of intraperitoneal drainage, length of antibiotic therapy, blood index changes, rate of infectious and non-infectious complications, postoperative hospital stay, and mortality were investigated. The patient demographics were not significantly different (p > 0.05) between the probiotic treated and the placebo groups. The days to first flatus (3.63 versus 3.27, p = 0.0274) and the days to first defecation (4.53 versus 3.87, p = 0.0268) were significantly improved in the probiotic treated patients. The incidence of diarrhea was significantly lower (p = 0.0352) in probiotics group (26.67%, 8/30) compared to the placebo group (53.33%, 16/30). There were no statistical differences (p > 0.05) in other infectious and non-infectious complication rates including wound infection, pneumonia, urinary tract infection, anastomotic leakage, and abdominal distension. In conclusion, for those patients undergoing confined CRC resection, perioperative probiotic administration significantly influenced the recovery of bowel function, and such improvement may be of important clinical significance in reducing the short-term infectious complications such as bacteremia.

Probiotics

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Gupta V

2009-01-01

Full Text Available The term "probiotic" was first used in 1965, by Lilly and Stillwell, to describe substances secreted by one organism which stimulate the growth of another. The use of antibiotics, immunosuppressive therapy and irradiation, amongst other means of treatment, may cause alterations in the composition and have an effect on the GIT flora. Therefore, the introduction of beneficial bacterial species to GI tract may be a very attractive option to re-establish the microbial equilibrium and prevent disease. Prebiotic is a non-digestible food ingredient that confers benefits on the host by selectively stimulating one bacterium or a group of bacteria in the colon with probiotic properties. Both probiotics and prebiotics are together called as Synbiotics. Various bacterial genera most commonly used in probiotic preparations are Lactobacillus, Bifidobacterium, Escherichia, Enterococcus, Bacillus and Streptococcus . Some fungal strains belonging to Saccharomyces have also been used. Probiotics have been shown to be effective in varied clinical conditions- ranging from infantile diarrhoea, necrotizing enterocolitis, antibiotic-associated diarrhoea, relapsing Clostridium difficle colitis, Helicobacter pylori infections, inflammatory bowel disease to cancer, female uro-genital infection and surgical infections. Lactobacillus rhamnosus strain GG has proven beneficial affects on intestinal immunity. It increases the number of IgA and other immunoglobulins secreting cells in the intestinal mucosa. It also stimulates local release of interferons. It facilitates antigen transport to underlying lymphoid cells, which serves to increase antigen uptake in Peyer′s patches. Probiotics are live microorganisms, so it is possible that they may result in infection in the host. The risk and morbidity of sepsis due to probiotic bacteria should be weighed against the potential for sepsis due to more pathological bacteria and the morbidity of diseases for which probiotic bacteria

The Effect of Probiotic Supplementations on Cognitive Function in Patients with Primary and Secondary Alzheimer

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Azadeh Agahi

2018-03-01

Full Text Available Abstract Background: Alzheimer’s disease (AD is a most common neurodegenerative disorder. The aim of this study was to investigate the effect of probiotic on cognitive function in patients with Alzheimer disease. Materials and Methods: This clinical trial was conducted among 48 AD patients. The patients were randomly divided into two groups (n=23 in control group and n=25 in probiotic group treating with capsules 500mg containing maltodextrine (control group and probiotic supplementation (probiotic group for 12 weeks. Mini-mental state examination (MMSE and TYM test score was recorded in all subjects before and after treatment. Results: After 12 weeks intervention, compared with the control group, the probiotic treated, patients with mild degree of Alzheimer disease showed an improvement in the MMSE, TYM score (p < 0.0001. Conclusion: Our current study demonstrated that probiotic consumption for 12 weeks positively affects cognitive function in mild degree of AD.

New insights on the use of dietary poliphenols or probiotics for the managment of arterial hypertension

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Jose Luiz De Brito Alves

2016-10-01

Full Text Available Arterial hypertension (AH is one of the most prevalent risk factors for cardiovascular diseases (CD and is the main cause of deaths worldwide. Current research establish that dietary polyphenols may help to lower blood pressure (BP, thus contributing to the reduction of cardiovascular complications. In addition, the health benefits of probiotics on BP have also attracted increased attention, as probiotics administration modulates the microbiota, which, by interacting with ingested polyphenols, controls their bioavalability. The aim of the present mini-review is to summarize and clarify the effects of dietary polyphenols and probiotics administration on BP using combined evidence from clinical and experimental studies, as well as to discuss the current debate in the literature about the usefulness of this nutritional approach to manage BP. Clinical trials and experimental studies have demonstrated that consuming dietary polyphenols or probiotics in adequate amounts may improve BP, ranging from modest to greater effects. However, the mechanisms linking probiotic intake and reduced BP levels need to be further elucidated as a definitive consensus on the link between intake of polyphenols or probiotics and improvement of AH has not been reached yet.

Effect of probiotics supplementation of cassava-groundnut cake ...

African Journals Online (AJOL)

In a 56 days feeding trial, eighteen starting pigs with initial body weight of 6.78 ± 0.5 kg were assigned randomly to 2 dietary treatment groups of nine pigs each (3 pens of 3 pigs each). Diet I was the control, which was not supplemented with probiotics, while Diet II was supplemented with 0.05% probiotics (probiotics ...

Effects of a Multispecies Probiotic Mixture on Glycemic Control and Inflammatory Status in Women with Gestational Diabetes: A Randomized Controlled Clinical Trial

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Sadegh Jafarnejad

2016-01-01

Full Text Available Objective. This trial aims to examine the effects of a Probiotic Mixture (VSL#3 on glycemic status and inflammatory markers, in women with GDM. Materials and Methods. Over a period of 8 weeks, 82 women with gestational diabetes were randomly assigned to either an intervention group (n=41 which were given VSL#3 capsule or to a control group which were given placebo capsule (n=41. Fasting plasma glucose, homeostatic model assessment of insulin resistance, glycosylated hemoglobin, high-sensitivity C-reactive protein, tumor necrosis factor-α, interleukin-6, Interferon gamma, and interleukin-10 were measured before and after the intervention. Results. After 8 wk of supplementation FPG, HbA1c, HOMA-IR, and insulin levels remained unchanged in the probiotic and placebo groups. The comparison between the two groups showed no significant differences with FPG and HbA1c, but there were significant differences in insulin levels and HOMA-IR (16.6±5.9; 3.7±1.5, resp.. Unlike the levels of IFN-g (19.21±16.6, there was a significant decrease in levels of IL-6 (3.81±0.7, TNF-α (3.10±1.1, and hs-CRP (4927.4±924.6. No significant increase was observed in IL-10 (3.11±5.7 in the intervention group as compared with the control group. Conclusions. In women with GDM, supplementation with probiotics (VSL#3 may help to modulate some inflammatory markers and may have benefits on glycemic control.

Effect of probiotics on vaginal health in pregnancy. EFFPRO, a randomized controlled trial.

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Gille, Christian; Böer, Bettina; Marschal, Matthias; Urschitz, Michael S; Heinecke, Volker; Hund, Verena; Speidel, Sarah; Tarnow, Inge; Mylonas, Ioannis; Franz, Axel; Engel, Corinna; Poets, Christian F

2016-11-01

Preterm delivery is a leading cause of neonatal morbidity and death. It often results from chorioamnionitis, which is a complication of bacterial vaginosis. Probiotics are effective in the treatment of bacterial vaginosis in women who were not pregnant; studies in pregnant woman are missing. The purpose of this study was to evaluate whether an oral probiotic food supplement supports the maintenance or restoration of a normal vaginal microbiota during pregnancy. We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (10 9 colony-forming units) or placebo were administered for 8 weeks to women with Vaginal swabs were taken before and after intervention and analyzed according to the Nugent scoring system. Telephone interviews were performed before and after intervention and after delivery. Primary outcome was the proportion of swabs with normal Nugent score (Vaginal swabs were analyzed from 290 women before and 271 women after intervention. The proportion of normal vaginal microbiota decreased from 82.6 to 77.8% in the treatment group and from 79.1 to 74.3% in the placebo group, with no significant difference across groups after intervention (P=.297). Oral probiotics may be suitable for implementation in antenatal care but, as administered here, had no effect on vaginal health during mid gestation. Other application routes or probiotic preparations may be more effective in supporting vaginal microbiota during pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

The role of probiotic bacteria in managing periodontal disease: a systematic review.

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Matsubara, Victor Haruo; Bandara, H M H N; Ishikawa, Karin Hitomi; Mayer, Marcia Pinto Alves; Samaranayake, Lakshman Perera

2016-07-01

The frequent recolonization of treated sites by periodontopathogens and the emergence of antibiotic resistance have led to a call for new therapeutic approaches for managing periodontal diseases. As probiotics are considered a new tool for combating infectious diseases, we systematically reviewed the evidences for their effectiveness in the management of periodontitis. An electronic search was performed in the MEDLINE, SCOPUS and Cochrane Library databases up to March 2016 using the terms 'periodontitis', 'chronic periodontitis', 'probiotic(s)', 'prebiotic(s)', 'symbiotic(s)', 'Bifidobacterium and 'Lactobacillus'. Only randomized controlled trials (RCTs) were included in the present study. Analysis of 12 RCTs revealed that in general, oral administration of probiotics improved the recognized clinical signs of chronic and aggressive periodontitis such as probing pocket depth, bleeding on probing, and attachment loss, with a concomitant reduction in the levels of major periodontal pathogens. Continuous probiotic administration, laced mainly with Lactobacillus species, was necessary to maintain these benefits. Expert commentary: Oral administration of probiotics is a safe and effective adjunct to conventional mechanical treatment (scaling) in the management of periodontitis, specially the chronic disease entity. Their adjunctive use is likely to improve disease indices and reduce the need for antibiotics.

Clinical Trials

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Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

Effectiveness of probiotics in the prevention of carious lesions during treatment with fixed orthodontic appliances.

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Paula Contreras

2017-07-01

Full Text Available The difficulty experienced by patients with fixed orthodontic appliances in maintaining adequate oral hygiene poses a risk for dental caries. The use of probiotics has been proposed as a means of prevention. The following systematic review aims to determine the effectiveness of probiotics in the prevention of dental caries during treatment with fixed orthodontic appliances. This review was carried out according to the PRISMA guidelines. A comprehensive electronic search was conducted in the Cochrane Library, EMBASE, PubMed and Google Scholar Beta databases. The inclusion criteria included randomized controlled clinical trials involving the use of probiotics, caries and patients under fixed orthodontic treatment. The methodological quality of the articles was evaluated according to risk of bias. Of the five included studies, three reported significant differences compared to the control group. Of the others, one article reported significant decrease in the final count of microorganisms compared to the beginning of treatment. Only one study reported no differences of any kind. It was estimated that the eligible studies were of moderate methodological quality and had an unclear risk of bias, without affecting key domains for the research. It is concluded that the daily consumption of probiotics can be effective in the prevention of carious lesions in patients under fixed orthodontic treatment. However, this should be interpreted with caution and corroborated by clinical trials of better methodological quality.

The Efficacy of Probiotic in Adults with Acute Infectious Diarrhea

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Mawin Mahen

2017-04-01

Full Text Available Diarrhea is a global health problem with high morbidity and mortality. In developing countries, acute diarrhea is most commonly caused by infectious pathogens. Regardless of the cause, diarrhea is primarily treated by fluid replacement therapy to decrease the risk of dehydration and death, although it does not affect the duration of diarrhea. Probiotics are able to shorten the duration of diarrhea in children, but its efficacy in adults is unclear. This study aimed to evaluate the benefit of probiotic in reducing the duration of acute diarrhea in adults as compared to placebo. Systematic search was done using four databases: PubMed, Scopus, ProQuest, and Embase, without limit on the year of publication. Randomized clinical trials were selected as the appropriate study design to answer the clinical question and two studies were considered relevant for appraisal. In conclusion, probiotics could improve the recovery of acute infectious diarrhea in adults (level of evidence 1b however more studies should be carried out since only very few strains of probiotics have been investigated. Keywords: probiotics, treatment efficacy, acute diarrhea, adults.     Efektivitas Probiotik pada Orang Dewasa dengan Diare:  Sebuah Laporan Kasus Berbasis Bukti   Abstrak Diare merupakan masalah kesehatan global dengan angka morbiditas dan mortalitas yang tinggi. Di negara berkembang, diare akut biasanya disebabkan oleh infeksi. Terlepas dari penyebabnya, tata laksana utama diare adalah terapi rehidrasi untuk mengurangi dehidrasi dan kematian walaupun hal tersebut tidak memengaruhi durasi diare. Probiotik dapat memperpendek durasi diare pada anak-anak, namun efektivitasnya pada orang dewasa masih belum jelas. Tujuan penelitian ini adalah untuk mengevaluasi efek probiotik dalam mengurangi durasi diare akut pada orang dewasa dibandingkan plasebo. Pencarian sistematik dilakukan pada empat database: PubMed, Scopus, ProQuest, dan Embase, tanpa membatasi tahun publikasi

Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice – an evidence-based international guide

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Hungin, A P S; Mulligan, C; Pot, B; Whorwell, P; Agréus, L; Fracasso, P; Lionis, C; Mendive, J; Philippart de Foy, J-M; Rubin, G; Winchester, C; Wit, N

2013-01-01

BackgroundEvidence suggests that the gut microbiota play an important role in gastrointestinal problems. AimTo give clinicians a practical reference guide on the role of specified probiotics in managing particular lower gastrointestinal symptoms/problems by means of a systematic review-based consensus. MethodsSystematic literature searching identified randomised, placebo-controlled trials in adults; evidence for each symptom/problem was graded and statements developed (consensus process; 10-member panel). As results cannot be generalised between different probiotics, individual probiotics were identified for each statement. ResultsThirty seven studies were included; mostly on irritable bowel syndrome [IBS; 19 studies; treatment responder rates: 18–80% (specific probiotics), 5–50% (placebo)] or antibiotic-associated diarrhoea (AAD; 10 studies). Statements with 100% agreement and ‘high’ evidence levels indicated that: (i) specific probiotics help reduce overall symptom burden and abdominal pain in some IBS patients; (ii) in patients receiving antibiotics/Helicobacter pylori eradication therapy, specified probiotics are helpful as adjuvants to prevent/reduce the duration/intensity of AAD; (iii) probiotics have favourable safety in patients in primary care. Items with 70–100% agreement and ‘moderate’ evidence were: (i) specific probiotics help relieve overall symptom burden in some patients with diarrhoea-predominant IBS, and reduce bloating/distension and improve bowel movement frequency/consistency in some IBS patients and (ii) with some probiotics, improved symptoms have led to improvement in quality of life. ConclusionsSpecified probiotics can provide benefit in IBS and antibiotic-associated diarrhoea; relatively few studies in other indications suggested benefits warranting further research. This study provides practical guidance on which probiotic to select for a specific problem. PMID:23981066

Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial

DEFF Research Database (Denmark)

Begtrup, Luise Mølenberg; de Muckadell, Ove B Schaffalitzky; Kjeldsen, Jens

2013-01-01

OBJECTIVE. Meta-analyses have indicated effect of probiotics on irritable bowel syndrome (IBS). However, few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting. We aimed to investigate the effect of probiotics compared...... with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up. MATERIAL AND METHODS. We randomized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp....../67) in the probiotic group versus 41% (26/64) in the placebo group, p = 0.18. Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment. Patients improved in HrQOL, but with no statistically significant difference between the groups. CONCLUSION. During a 6-month treatment...

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Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

Folate Production by Probiotic Bacteria

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Stefano Raimondi

2011-01-01

Full Text Available Probiotic bacteria, mostly belonging to the genera Lactobacillus and Bifidobacterium, confer a number of health benefits to the host, including vitamin production. With the aim to produce folate-enriched fermented products and/or develop probiotic supplements that accomplish folate biosynthesis in vivo within the colon, bifidobacteria and lactobacilli have been extensively studied for their capability to produce this vitamin. On the basis of physiological studies and genome analysis, wild-type lactobacilli cannot synthesize folate, generally require it for growth, and provide a negative contribution to folate levels in fermented dairy products. Lactobacillus plantarum constitutes an exception among lactobacilli, since it is capable of folate production in presence of para-aminobenzoic acid (pABA and deserves to be used in animal trials to validate its ability to produce the vitamin in vivo. On the other hand, several folate-producing strains have been selected within the genus Bifidobacterium, with a great variability in the extent of vitamin released in the medium. Most of them belong to the species B. adolescentis and B. pseudocatenulatum, but few folate producing strains are found in the other species as well. Rats fed a probiotic formulation of folate-producing bifidobacteria exhibited increased plasma folate level, confirming that the vitamin is produced in vivo and absorbed. In a human trial, the same supplement raised folate concentration in feces. The use of folate-producing probiotic strains can be regarded as a new perspective in the specific use of probiotics. They could more efficiently confer protection against inflammation and cancer, both exerting the beneficial effects of probiotics and preventing the folate deficiency that is associated with premalignant changes in the colonic epithelia.

[Promissing role of probiotics in prevention of smoking-related diseases].

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Hozyasz, Kamil K

2008-01-01

Humans are highly adapted to consuming probiotics. Trehalose ("mushroom" sugar) is probably an important reserve compound and stress-responsible metabolite (increases bile and gastric acid resistance) of probiotic bacteria's and trehalase activity, in contrast to lactase activity, is preserved in all human populations, even those not consuming mushrooms. Among traditional Melanesian horticulturists, of whom 4/5 are daily smokers, the diet is rich in pre- and probiotics and there is absence of cancer and cardiovascular disease. Indoor air pollution is an important cancer risk factor. Over thousands of years, the controlled use of fire for preparing meals has resulted in exposure to smoke pollution (biomass fuels produce up to 100 times more respirable particles compared to gas ovens). Simultaneously, up until the 20th century, the only commonly available and inexpensive way of preserving food was fermentation and drying. Probiotics may protect the detoxification function of the kidney and liver. Furthermore, it can be speculated that probiotics may help in adaptation to smoke pollution generated during cooking, heating but also tobacco smoking. Smoking is the most important lifestyle risk factor for bladder cancer and the consumption of probiotic foods reduces the risk of this cancer in humans. Probiotics may restore natural killer cell activity which is lowered in smokers. In one study it was observed that a diet supplemented with Lactobacillus plantarum could be also useful in the prevention of cardiovascular disease in smokers. There is no sufficient data from clinical trials to recommend the routine use of probiotics in prevention of smoking-related diseases. More research is needed to investigate the role of probiotics in this area.

Probiotics for preventing gestational diabetes.

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Barrett, Helen L; Dekker Nitert, Marloes; Conwell, Louise S; Callaway, Leonie K

2014-02-27

Gestational diabetes mellitus (GDM) is associated with a range of adverse pregnancy outcomes for mother and infant. The prevention of GDM using lifestyle interventions has proven difficult. The gut microbiome (the composite of bacteria present in the intestines) influences host inflammatory pathways, glucose and lipid metabolism and, in other settings, alteration of the gut microbiome has been shown to impact on these host responses. Probiotics are one way of altering the gut microbiome but little is known about their use in influencing the metabolic environment of pregnancy. To assess the effects of probiotic supplementation when compared with other methods for the prevention of GDM. We searched the Cochrane Pregnancy and childbirth Group's Trials Register (31 August 2013) and reference lists of the articles of retrieved studies. Randomised and cluster-randomised trials comparing the use of probiotic supplementation with other methods for the prevention of the development of GDM. Cluster-randomised trials were eligible for inclusion but none were identified. Quasi-randomised and cross-over design studies are not eligible for inclusion in this review. Studies presented only as abstracts with no subsequent full report of study results would also have been excluded. Two review authors independently assessed study eligibility, extracted data and assessed risk of bias of included study. Data were checked for accuracy. Eleven reports (relating to five possible trials) were found. We included one study (six trial reports) involving 256 women. Four other studies are ongoing.The included trial consisted of three treatment arms: probiotic with dietary intervention, placebo and dietary intervention, and dietary intervention alone; it was at a low risk of bias. The study reported primary outcomes of a reduction in the rate of gestational diabetes mellitus (risk ratio (RR) 0.38, 95% confidence interval (CI) 0.20 to 0.70), with no statistical difference in the rates of

Probiotics and prebiotics in dermatology.

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Baquerizo Nole, Katherine L; Yim, Elizabeth; Keri, Jonette E

2014-10-01

The rapid increase in the medical use of probiotics and prebiotics in recent years has confirmed their excellent safety profile. As immune modulators, they have been used in inflammatory skin conditions, such as atopic dermatitis. We review the literature regarding the use of probiotics and prebiotics in dermatology. Probiotics and prebiotics appear to be effective in reducing the incidence of atopic dermatitis in infants, but their role in atopic dermatitis treatment is controversial. Their role in acne, wound healing, and photoprotection is promising, but larger trials are needed before a final recommendation can be made. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Probiotics for gastrointestinal disorders: Proposed recommendations for children of the Asia-Pacific region

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Cameron, Donald; Hock, Quak Seng; Kadim, Musal; Mohan, Neelam; Ryoo, Eell; Sandhu, Bhupinder; Yamashiro, Yuichiro; Jie, Chen; Hoekstra, Hans; Guarino, Alfredo

2017-01-01

Recommendations for probiotics are available in several regions. This paper proposes recommendations for probiotics in pediatric gastrointestinal diseases in the Asia-Pacific region. Epidemiology and clinical patterns of intestinal diseases in Asia-Pacific countries were discussed. Evidence-based recommendations and randomized controlled trials in the region were revised. Cultural aspects, health management issues and economic factors were also considered. Final recommendations were approved by applying the Likert scale and rated using the GRADE system. Saccharomyces boulardii CNCM I-745 (Sb) and Lactobacillus rhamnosus GG (LGG) were strongly recommended as adjunct treatment to oral rehydration therapy for gastroenteritis. Lactobacillus reuteri could also be considered. Probiotics may be considered for prevention of (with the indicated strains): antibiotic-associated diarrhea (LGG or Sb); Clostridium difficile-induced diarrhea (Sb); nosocomial diarrhea (LGG); infantile colic (L reuteri) and as adjunct treatment of Helicobacter pylori (Sb and others). Specific probiotics with a history of safe use in preterm and term infants may be considered in infants for prevention of necrotizing enterocolitis. There is insufficient evidence for recommendations in other conditions. Despite a diversity of epidemiological, socioeconomical and health system conditions, similar recommendations apply well to Asia pacific countries. These need to be validated with local randomized-controlled trials. PMID:29259371

Combined bioavailable isoflavones and probiotics improve bone status and estrogen metabolism in postmenopausal osteopenic women: a randomized controlled trial

DEFF Research Database (Denmark)

Lambert, Max Norman Tandrup; Thybo, Catrine Bundgaard; Lykkeboe, Simon

2017-01-01

estrogen receptor affinity show potential to prevent and treat osteoporosis while minimizing or eliminating carcinogenic side effects. Objective: In this study, we sought to determine the beneficial effects of a bioavailable isoflavone and probiotic treatment against postmenopausal osteopenia. Design: We...... used a novel red clover extract (RCE) rich in isoflavone aglycones and probiotics to concomitantly promote uptake and a favorable intestinal bacterial profile to enhance isoflavone bioavailability. This was a 12-mo, double-blind, parallel design, placebo-controlled, randomized controlled trial of 78...... postmenopausal osteopenic women supplemented with calcium (1200 mg/d), magnesium (550 mg/d), and calcitriol (25 mg/d) given either RCE (60 mg isoflavone aglycones/d and probiotics) or a masked placebo [control (CON)]. Results: RCE significantly attenuated bone mineral density (BMD) loss at the L2–L4 lumbar spine...

Clinical Trials

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Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

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Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

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Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

Probiotics for the Prevention of Pediatric Antibiotic-Associated Diarrhea.

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Hayes, Shelby R; Vargas, Ashley J

Goldenberg JZ, Lytvyn L, Steurich J, Parkin P, Mahant S, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea.Cochrane Database Syst Rev2015, Issue 12. Art. No.: CD004827. http://dx.doi.org/10.1002/14651858.CD004827.pub4. Antibiotics are frequently prescribed in children. They alter the microbial balance within the gastrointestinal tract, commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via restoration of the gut microflora. The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children. MEDLINE, EMBASE, CENTRAL, CINAHL, AMED, and the Web of Science (inception to November 2014) were searched along with specialized registers including the Cochrane IBD/FBD review group, CISCOM (Centralized Information Service for Complementary Medicine), NHS Evidence, the International Bibliographic Information on Dietary Supplements, as well as trial registries. Letters were sent to authors of included trials, nutraceutical and pharmaceutical companies, and experts in the field requesting additional information on ongoing or unpublished trials. Conference proceedings, dissertation abstracts, and reference lists from included and relevant articles were also searched. Randomized, parallel, controlled trials in children (0-18 years) receiving antibiotics, that compare probiotics to placebo, active alternative prophylaxis, or no treatment and measure the incidence of diarrhea secondary to antibiotic use were considered for inclusion. Study selection, data extraction, and methodological quality assessment using the risk of bias instrument were conducted independently and in duplicate by two authors. Dichotomous data (incidence of diarrhea and adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea and mean daily stool frequency) as mean difference (MD

Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children.

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Goldenberg, Joshua Z; Yap, Christina; Lytvyn, Lyubov; Lo, Calvin Ka-Fung; Beardsley, Jennifer; Mertz, Dominik; Johnston, Bradley C

2017-12-19

Antibiotics can disturb gastrointestinal microbiota which may lead to reduced resistance to pathogens such as Clostridium difficile (C. difficile). Probiotics are live microbial preparations that, when administered in adequate amounts, may confer a health benefit to the host, and are a potential C. difficile prevention strategy. Recent clinical practice guidelines do not recommend probiotic prophylaxis, even though probiotics have the highest quality evidence among cited prophylactic therapies. To assess the efficacy and safety of probiotics for preventing C.difficile-associated diarrhea (CDAD) in adults and children. We searched PubMed, EMBASE, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 21 March 2017. Additionally, we conducted an extensive grey literature search. Randomized controlled (placebo, alternative prophylaxis, or no treatment control) trials investigating probiotics (any strain, any dose) for prevention of CDAD, or C. difficile infection were considered for inclusion. Two authors (independently and in duplicate) extracted data and assessed risk of bias. The primary outcome was the incidence of CDAD. Secondary outcomes included detection of C. difficile infection in stool, adverse events, antibiotic-associated diarrhea (AAD) and length of hospital stay. Dichotomous outcomes (e.g. incidence of CDAD) were pooled using a random-effects model to calculate the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. Continuous outcomes (e.g. length of hospital stay) were pooled using a random-effects model to calculate the mean difference and corresponding 95% CI. Sensitivity analyses were conducted to explore the impact of missing data on efficacy and safety outcomes. For the sensitivity analyses, we assumed that the event rate for those participants in the control group who had missing data was the same as the

Intestinal microbiota, probiotics and prebiotics in inflammatory bowel disease

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Orel, Rok; Kamhi Trop, Tina

2014-01-01

It has been presumed that aberrant immune response to intestinal microorganisms in genetically predisposed individuals may play a major role in the pathogenesis of the inflammatory bowel disease, and there is a good deal of evidence supporting this hypothesis. Commensal enteric bacteria probably play a central role in pathogenesis, providing continuous antigenic stimulation that causes chronic intestinal injury. A strong biologic rationale supports the use of probiotics and prebiotics for inflammatory bowel disease therapy. Many probiotic strains exhibit anti-inflammatory properties through their effects on different immune cells, pro-inflammatory cytokine secretion depression, and the induction of anti-inflammatory cytokines. There is very strong evidence supporting the use of multispecies probiotic VSL#3 for the prevention or recurrence of postoperative pouchitis in patients. For treatment of active ulcerative colitis, as well as for maintenance therapy, the clinical evidence of efficacy is strongest for VSL#3 and Escherichia coli Nissle 1917. Moreover, some prebiotics, such as germinated barley foodstuff, Psyllium or oligofructose-enriched inulin, might provide some benefit in patients with active ulcerative colitis or ulcerative colitis in remission. The results of clinical trials in the treatment of active Crohn’s disease or the maintenance of its remission with probiotics and prebiotics are disappointing and do not support their use in this disease. The only exception is weak evidence of advantageous use of Saccharomyces boulardii concomitantly with medical therapy in maintenance treatment. PMID:25206258

Discovering probiotic microorganisms: in vitro, in vivo, genetic and omics approaches.

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Papadimitriou, Konstantinos; Zoumpopoulou, Georgia; Foligné, Benoit; Alexandraki, Voula; Kazou, Maria; Pot, Bruno; Tsakalidou, Effie

2015-01-01

Over the past decades the food industry has been revolutionized toward the production of functional foods due to an increasing awareness of the consumers on the positive role of food in wellbeing and health. By definition probiotic foods must contain live microorganisms in adequate amounts so as to be beneficial for the consumer's health. There are numerous probiotic foods marketed today and many probiotic strains are commercially available. However, the question that arises is how to determine the real probiotic potential of microorganisms. This is becoming increasingly important, as even a superficial search of the relevant literature reveals that the number of proclaimed probiotics is growing fast. While the vast majority of probiotic microorganisms are food-related or commensal bacteria that are often regarded as safe, probiotics from other sources are increasingly being reported raising possible regulatory and safety issues. Potential probiotics are selected after in vitro or in vivo assays by evaluating simple traits such as resistance to the acidic conditions of the stomach or bile resistance, or by assessing their impact on complicated host functions such as immune development, metabolic function or gut-brain interaction. While final human clinical trials are considered mandatory for communicating health benefits, rather few strains with positive studies have been able to convince legal authorities with these health claims. Consequently, concern has been raised about the validity of the workflows currently used to characterize probiotics. In this review we will present an overview of the most common assays employed in screening for probiotics, highlighting the potential strengths and limitations of these approaches. Furthermore, we will focus on how the advent of omics technologies has reshaped our understanding of the biology of probiotics, allowing the exploration of novel routes for screening and studying such microorganisms.

Discovering probiotic microorganisms: in vitro, in vivo, genetic and omics approaches

Directory of Open Access Journals (Sweden)

Konstantinos ePapadimitriou

2015-02-01

Full Text Available Over the past decades the food industry has been revolutionized towards the production of functional foods due to an increasing awareness of the consumers on the positive role of food in wellbeing and health. By definition probiotic foods must contain live microorganisms in adequate amounts so as to be beneficial for the consumer’s health. There are numerous probiotic foods marketed today and many probiotic strains are commercially available. However, the question that arises is how to determine the real probiotic potential of microorganisms. This is becoming increasingly important, as even a superficial search of the relevant literature reveals that the number of proclaimed probiotics is growing fast. While the vast majority of probiotic microorganisms are food-related or commensal bacteria that are often regarded as safe, probiotics from other sources are increasingly being reported raising possible regulatory and safety issues. Potential probiotics are selected after in vitro or in vivo assays by evaluating simple traits such as resistance to the acidic conditions of the stomach or bile resistance, or by assessing their impact on complicated host functions such as immune development, metabolic function or gut-brain interaction. While final human clinical trials are considered mandatory for communicating health benefits, rather few strains with positive studies have been able to convince legal authorities with these health claims. Consequently, concern has been raised about the validity of the workflows currently used to characterize probiotics. In this review we will present an overview of the most common assays employed in screening for probiotics, highlighting the potential strengths and limitations of these approaches. Furthermore, we will focus on how the advent of omics technologies has reshaped our understanding of the biology of probiotics, allowing the exploration of novel routes for screening and studying such microorganisms.

Discovering probiotic microorganisms: in vitro, in vivo, genetic and omics approaches

Science.gov (United States)

Papadimitriou, Konstantinos; Zoumpopoulou, Georgia; Foligné, Benoit; Alexandraki, Voula; Kazou, Maria; Pot, Bruno; Tsakalidou, Effie

2015-01-01

Over the past decades the food industry has been revolutionized toward the production of functional foods due to an increasing awareness of the consumers on the positive role of food in wellbeing and health. By definition probiotic foods must contain live microorganisms in adequate amounts so as to be beneficial for the consumer’s health. There are numerous probiotic foods marketed today and many probiotic strains are commercially available. However, the question that arises is how to determine the real probiotic potential of microorganisms. This is becoming increasingly important, as even a superficial search of the relevant literature reveals that the number of proclaimed probiotics is growing fast. While the vast majority of probiotic microorganisms are food-related or commensal bacteria that are often regarded as safe, probiotics from other sources are increasingly being reported raising possible regulatory and safety issues. Potential probiotics are selected after in vitro or in vivo assays by evaluating simple traits such as resistance to the acidic conditions of the stomach or bile resistance, or by assessing their impact on complicated host functions such as immune development, metabolic function or gut–brain interaction. While final human clinical trials are considered mandatory for communicating health benefits, rather few strains with positive studies have been able to convince legal authorities with these health claims. Consequently, concern has been raised about the validity of the workflows currently used to characterize probiotics. In this review we will present an overview of the most common assays employed in screening for probiotics, highlighting the potential strengths and limitations of these approaches. Furthermore, we will focus on how the advent of omics technologies has reshaped our understanding of the biology of probiotics, allowing the exploration of novel routes for screening and studying such microorganisms. PMID:25741323

Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review.

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Hanson, Lisa; VandeVusse, Leona; Jermé, Martha; Abad, Cybéle L; Safdar, Nasia

2016-05-01

Probiotics are a complementary and integrative therapy useful in the treatment and prevention of urogenital infections in women. This study extends the work of researchers who systematically investigated the scientific literature on probiotics to prevent or treat urogenital infections. A systematic review was conducted to determine the efficacy of probiotics for prevention and/or treatment of urogenital infections in adult women from January 1, 2008, through June 30, 2015. We searched in CINAHL, MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, Dissertations and Theses, and Alt-HealthWatch. After removing duplicates and studies that did not meet inclusion criteria, 20 studies were reviewed. All included at least one species of Lactobacillus probiotic as an intervention for treatment or prevention of urogenital infections. Data extracted included samples, settings, study designs, intervention types, reported outcomes, follow-up periods, and results. We evaluated all randomized controlled trials for risk of bias and made quality appraisals on all studies. Fourteen of the studies focused on bacterial vaginosis (BV), 3 on urinary tract infections (UTIs), 2 on vulvovaginal candidiasis, and one on human papillomavirus (HPV) as identified on Papanicolaou test. Studies were heterogeneous in terms of design, intervention, and outcomes. Four studies were of good quality, 9 of fair, and 7 poor. Probiotic interventions were effective for treatment and prevention of BV, prevention of recurrences of candidiasis and UTIs, and clearing HPV lesions. No study reported significant adverse events related to the probiotic intervention. The quality of the studies in this systematic review varied. Although clinical practice recommendations were limited by the strength of evidence, probiotic interventions were effective in treatment and prevention of urogenital infections as alternatives or co-treatments. More good quality research is needed to strengthen the body

Probiotics for future caries control: A short-term clinical study

Directory of Open Access Journals (Sweden)

Anitha Chinnappa

2013-01-01

Full Text Available Objectives: To compare mutans streptococci levels in saliva, before and after consumption of probiotic ice-cream and curds. Materials and Methods: Forty caries free children in the age group of 12-14 years were selected and equally divided into four groups I, II, III, IV. Children in group I and II were given 100 ml probiotic ice-cream and plain ice cream respectively and group III and IV were given 100 ml probiotic curd and plain curd respectively for a period of 7 days. Saliva samples were assessed at baseline, 1 hour after consumption and after 7 days intervention period using Mitis salivarius Bacitracin agar. The number of colonies was counted and subjected to statistical analysis. Results: The study revealed a reduction in salivary mutans streptococci (MS counts after 1 hour in all the groups. However after 7 days, probiotic ice-cream and curd showed a statistically significant (P < 0.001 reduction in MS counts as compared to the control ice cream and curd. The difference in the reduction of MS counts with probiotic ice-cream and probiotic curd at 1 hour and 7 days was not statistically significant. Conclusion: The use of probiotic products could be an alternative strategy of displacing pathogenic microorganisms by probiotic bacteria and can thus be exploited for the prevention of enamel demineralization.

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The Effects of Probiotics and Symbiotics on Risk Factors for Hepatic Encephalopathy: A Systematic Review.

Science.gov (United States)

Viramontes Hörner, Daniela; Avery, Amanda; Stow, Ruth

2017-04-01

Alterations in the levels of intestinal microbiota, endotoxemia, and inflammation are novel areas of interest in the pathogenesis of hepatic encephalopathy (HE). Probiotics and symbiotics are a promising treatment option for HE due to possible beneficial effects in modulating gut microflora and might be better tolerated and more cost-effective than the traditional treatment with lactulose, rifaximin or L-ornithine-L-aspartate. A systematic search of the electronic databases PubMed, ISI Web of Science, EMBASE, and Cochrane Library was conducted for randomized controlled clinical trials in adult patients with cirrhosis, evaluating the effect of probiotics and symbiotics in changes on intestinal microflora, reduction of endotoxemia, inflammation, and ammonia, reversal of minimal hepatic encephalopathy (MHE), prevention of overt hepatic encephalopathy (OHE), and improvement of quality of life. Nineteen trials met the inclusion criteria. Probiotics and symbiotics increased beneficial microflora and decreased pathogenic bacteria and endotoxemia compared with placebo/no treatment, but no effect was observed on inflammation. Probiotics significantly reversed MHE [risk ratio, 1.53; 95% confidence interval (CI): 1.14, 2.05; P=0.005] and reduced OHE development (risk ratio, 0.62; 95% CI: 0.48, 0.80; P=0.0002) compared with placebo/no treatment. Symbiotics significantly decreased ammonia levels compared with placebo (15.24; 95% CI: -26.01, -4.47; P=0.006). Probiotics did not show any additional benefit on reversal of MHE and prevention of OHE development when compared with lactulose, rifaximin, and L-ornithine-L-aspartate. Only 5 trials considered tolerance with minimal side effects reported. Although further research is warranted, probiotics and symbiotics should be considered as an alternative therapy for the treatment and management of HE given the results reported in this systematic review.

Clinical Trials

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Clinical and Microbiological Effect of a Multispecies Probiotic Supplementation in Celiac Patients With Persistent IBS-type Symptoms: A Randomized, Double-Blind, Placebo-controlled, Multicenter Trial.

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Francavilla, Ruggiero; Piccolo, Maria; Francavilla, Antonio; Polimeno, Lorenzo; Semeraro, Francesco; Cristofori, Fernanda; Castellaneta, Stefania; Barone, Michele; Indrio, Flavia; Gobbetti, Marco; De Angelis, Maria

2018-04-23

The goals of this study were to evaluate the efficacy and safety of a probiotic mixture in patients with celiac disease (CD) with irritable bowel syndrome (IBS)-type symptoms despite a strict gluten-free diet (GFD). About 30% of patients with CD adherent to a GFD suffer from IBS-type symptoms; a possible cause resides in the imbalances of the intestinal microbiota in CD. Probiotics may represent a potential treatment. CD patients with IBS-type symptoms entered a prospective, double-blind, randomized placebo-controlled study. A 6-week treatment period was preceded by a 2-week run-in and followed by a 6-week follow-up phase. Clinical data were monitored throughout the study by validated questionnaires: IBS Severity Scoring System (IBS-SSS); Gastrointestinal Symptom Rating Scale (GSRS); Bristol Stool Form Scale (BSFS); and IBS Quality of Life Questionnaire (IBS-QOL). The fecal microbiota were assayed using plate counts and 16S rRNA gene-based analysis. In total, 109 patients were randomized to probiotics (n=54) or placebo (n=55). IBS-SSS and GSRS decreased significantly in probiotics, as compared with placebo [(-15.9%±14.8% vs. 8.2%±25.9%; Psymptoms, in CD patients on strict GFD, and is associated with a modification of gut microbiota, characterized by an increase of bifidobacteria.

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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

Probiotic treatment reduces depressive-like behaviour in rats independently of diet.

Science.gov (United States)

Abildgaard, Anders; Elfving, Betina; Hokland, Marianne; Wegener, Gregers; Lund, Sten

2017-05-01

The gut microbiota has recently emerged as an important regulator of brain physiology and behaviour in animals, and ingestion of certain bacteria (probiotics) therefore appear to be a potential treatment for major depressive disorder (MDD). However, some conceptual and mechanistical aspects need further elucidation. We therefore aimed at investigating whether the habitual diet may interact with the effect of probiotics on depression-related behaviour and further examined some potentially involved mechanisms underlying the microbe-mediated behavioural effects. Forty male Sprague-Dawley rats were fed a control (CON) or high-fat diet (HFD) for ten weeks and treated with either a multi-species probiotic formulation or vehicle for the last five weeks. Independently of diet, probiotic treatment markedly reduced depressive-like behaviour in the forced swim test by 34% (95% CI: 22-44%). Furthermore, probiotic treatment skewed the cytokine production by stimulated blood mononuclear cells towards IFNγ, IL2 and IL4 at the expense of TNFα and IL6. In addition, probiotics lowered hippocampal transcript levels of factors involved in HPA axis regulation (Crh-r1, Crh-r2 and Mr), whereas HFD increased these levels. A non-targeted plasma metabolomics analysis revealed that probiotics raised the level of indole-3-propionic acid, a potential neuroprotective agent. Our findings clearly support probiotics as a potential treatment strategy in MDD. Importantly, the efficacy was not attenuated by intake of a "Western pattern" diet associated with MDD. Mechanistically, the HPA axis, immune system and microbial tryptophan metabolism could be important in this context. Importantly, our study lend inspiration to clinical trials on probiotics in depressed patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Probiotics for the Treatment of Atopic Dermatitis in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Science.gov (United States)

Huang, Ruixue; Ning, Huacheng; Shen, Minxue; Li, Jie; Zhang, Jianglin; Chen, Xiang

2017-01-01

Objective: Atopic dermatitis (AD) is a prevalent, burdensome, and psychologically important pediatric concern. Probiotics have been suggested as a treatment for AD. Some reports have explored this topic; however, the utility of probiotics for AD remains to be firmly established. Methods: To assess the effects of probiotics on AD in children, the PubMed/Medline, Cochrane Library Scopus, and OVID databases were searched for reports published in the English language. Results: Thirteen studies were identified. Significantly higher SCORAD values favoring probiotics over controls were observed (mean difference [MD], -3.07; 95% confidence interval [CI], -6.12 to -0.03; P probiotics in children probiotics, whereas significantly lower SCORAD values were reported in Asia (MD, -5.39; 95%CI, -8.91 to -1.87). Lactobacillus rhamnosus GG (MD, 3.29; 95%CI, -0.30 to 6.88; P = 0.07) and Lactobacillus plantarum (MD, -0.70; 95%CI, -2.30 to 0.90; P = 0.39) showed no significant effect on SCORAD values in children with AD. However, Lactobacillus fermentum (MD, -11.42; 95%CI, -13.81 to -9.04), Lactobacillus salivarius (MD, -7.21; 95%CI, -9.63 to -4.78), and a mixture of different strains (MD, -3.52; 95%CI, -5.61 to -1.44) showed significant effects on SCORAD values in children with AD. Conclusions: Our meta-analysis indicated that the research to date has not robustly shown that probiotics are beneficial for children with AD. However, caution is needed when generalizing our results, as the populations evaluated were heterogeneous. Randomized controlled trials with larger samples and greater power are necessary to identify the species, dose, and treatment duration of probiotics that are most efficacious for treating AD in children.

Probiotics and inflammatory bowel disease: from fads and fantasy to facts and future.

LENUS (Irish Health Repository)

Shanahan, Fergus

2012-02-03

Probiotic therapy is attracting the renewed interest of clinicians and basic investigators from a variety of traditional research disciplines. While the theoretical rationale for modifying the commensal flora of the gastrointestinal tract in specific circumstances appears sound and requires scientific pursuit, the field of probiotics has been clouded by exaggerated claims from some quarters. In general, many of the claims for therapeutic efficacy have not been well substantiated, but the field is now poised for evaluation within the realm of evidence-based medicine. Alterations in commensal bacterial flora within the gastrointestinal tract are associated with susceptibility to pathogens such as Clostridium difficile and there is persuasive evidence that the normal flora may participate in the pathogenesis of inflammatory bowel disease and other chronic diseases in genetically susceptible individuals. This has prompted various strategies to fortify or otherwise modify the enteric flora by dietary supplements containing probiotic formulations. Detailed comparisons of probiotic performance amongst different bacterial strains have not been performed in vivo in man or under clinical trial conditions, and the level of scientific characterisation of individual organisms has been variable. In addition, it cannot be assumed that the same probiotic is equally suitable for all individuals. Moreover, the heterogeneity of clinical disorders such as Crohn\\'s disease and ulcerative colitis implies that strain-specific properties may be required for subset-specific categories of patients. While cocktails of probiotics offer convenience, therapeutic progress may require clarification of the mechanism of probiotic action and may be delayed until individual bacterial components have been rigorously studied. More importantly, the full potential of therapeutic manipulation of the enteric flora with probiotics or other strategies may not be optimally realised until the composition and

Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial.

Science.gov (United States)

Baldassarre, Maria Elisabetta; Di Mauro, Antonio; Mastromarino, Paola; Fanelli, Margherita; Martinelli, Domenico; Urbano, Flavia; Capobianco, Daniela; Laforgia, Nicola

2016-10-27

Probiotic supplementation to women during pregnancy and lactation can modulate breast milk composition, with immune benefits being transferred to their infants. The aim of the study was to evaluate the effect of high-dose probiotic supplementation to women during late pregnancy and lactation on cytokine profile and secretory IgA (sIgA) in breast milk and thus to study if differences in breast milk composition can affect lactoferrin and sIgA levels in stool samples of newborns. The safety of maternal probiotic administration on neonatal growth pattern and gastrointestinal symptoms were also evaluated. In a double-blind, placebo-controlled, randomized trial, 66 women took either the probiotic ( n = 33) or a placebo ( n = 33) daily. Levels of interleukins (IL-6, IL-10 and IL-1β), transforming growth factor-β1 (TGF-β1), and sIgA in breast milk; and the level of sIgA and lactoferrin in newborn stool samples were analyzed at birth and then again at one month of life. Antropometrical evaluation and analysis of gastrointestinal events in newborns was also performed. Probiotic maternal consumption had a significant impact on IL6 mean values in colostrum and on IL10 and TGF-β1 mean values in mature breast milk. Fecal sIgA mean values were higher in newborns whose mothers took the probiotic product than in the control group. Probiotic maternal supplementation seems to decrease incidence of infantile colic and regurgitation in infants. High-dose multi-strain probiotic administration to women during pregnancy influences breast milk cytokines pattern and sIgA production in newborns, and seems to improve gastrointestinal functional symptoms in infants.

Clinical Trials

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Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

Ok, so who wants to colonise my gut? - Overview of Probiotics in ...

African Journals Online (AJOL)

Probiotics are not currently regulated and only few authoritative randomised controlled trials exist investigating their efficacy in different GI disorders. The efficacy of probiotics, as either a single strain or a combination of probiotics, has been assessed in antibioticassociated diarrhoea, Clostridium difficile colitis, infectious ...

The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world.

Science.gov (United States)

Dronkers, T M G; Krist, L; Van Overveld, F J; Rijkers, G T

2018-05-25

The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

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Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

Intestinal Barrier Dysfunction in a Randomized Trial of a Specific Probiotic Composition in Acute Pancreatitis

NARCIS (Netherlands)

Besselink, Marc G.; van Santvoort, Hjalmar C.; Renooij, Willem; de Smet, Martin B.; Boermeester, Marja A.; Fischer, Kathelijn; Timmerman, Harro M.; Ali, Usama Ahmed; Cirkel, Geert A.; Bollen, Thomas L.; van Ramshorst, Bert; Schaapherder, Alexander F.; Witteman, Ben J.; Ploeg, Rutger J.; van Goor, Harry; van Laarhoven, Cornelis J.; Tan, Adriaan C.; Brink, Menno A.; van der Harst, Erwin; Wahab, Peter J.; van Eijck, Casper H.; Dejong, Cornelis H.; van Erpecum, Karel J.; Akkermans, Louis M.; Gooszen, Hein G.

2009-01-01

Objectives: To determine the relation between intestinal barrier dysfunction, bacterial translocation, and clinical outcome in patients with predicted severe acute pancreatitis and the influence of probiotics on these processes. Summary of Background data: Randomized, placebo-controlled,

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Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

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Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

Effects of probiotic yogurt consumption on metabolic factors in individuals with nonalcoholic fatty liver disease.

Science.gov (United States)

Nabavi, S; Rafraf, M; Somi, M H; Homayouni-Rad, A; Asghari-Jafarabadi, M

2014-12-01

The aim of this study was to investigate the effects of probiotic yogurt consumption on some metabolic factors in nonalcoholic fatty liver disease (NAFLD) patients. This double-blind, randomized, controlled clinical trial was conducted on 72 patients with NAFLD (33 males and 39 females) aged 23 to 63 yr. Subjects in the intervention group (n=36) consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group (n=36) consumed 300 g/d of conventional yogurt for 8 wk. Fasting blood samples, anthropometric measurements, and dietary records (24h/d for 3 d) were collected at baseline and at the end of the trial. Probiotic yogurt consumption resulted in reductions of 4.67, 5.42, 4.1, and 6.92% in serum levels of alanine aminotransferase, aspartate aminotransferase, total cholesterol, and low-density lipoprotein cholesterol, respectively, compared with control group. No significant changes were observed in levels of serum glucose, triglycerides, or high-density lipoprotein cholesterol in either group. Probiotic yogurt consumption improved hepatic enzymes, serum total cholesterol, and low-density lipoprotein cholesterol levels in studied subjects and might be useful in management of NAFLD risk factors. Copyright © 2014 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Scientific evidence for health effects attributed to the consumption of probiotics and prebiotics: an update for current perspectives and future challenges.

Science.gov (United States)

Martinez, Rafael Chacon Ruiz; Bedani, Raquel; Saad, Susana Marta Isay

2015-12-28

Probiotics and prebiotics, mainly commercialised as food ingredients and also as supplements, are considered highly profitable niche markets. However, in recent years, the food industry has suffered from a series of health claim restrictions on probiotics and prebiotics in many parts of the world, including those made by the European Food Safety Authority. Therefore, we reviewed the core benefits of probiotic and prebiotic consumption on health. A number of studies have examined the prevention and/or management of intestinal infections, respiratory tract infections, CVD, osteoporosis, urogenital infections, cavities, periodontal disease and halitosis, allergic reactions, inflammatory bowel disease and irritable bowel syndrome and Helicobacter pylori gastric infections. In fact, a deeper understanding of the mechanisms involved in human microbiota and immune system modulation by probiotics and prebiotics relies on continuous efforts to establish suitable biomarkers of health and diseases risk factors for the design of clinical trials required for health claim approval. In spite of the promising results, the performance of large, long-term, well-planned, well-aligned clinical studies is crucial to provide more reliability and a more solid basis for the outcomes achieved and to support the potential use of probiotics and prebiotics in clinical practice.

Comparison between probiotic lozenges and drinks towards periodontal status improvement of orthodontic patients

Directory of Open Access Journals (Sweden)

Natasia Melita Kohar

2015-09-01

Full Text Available Background: Fixed orthodontic appliances may interfere with daily oral hygiene procedure, causing more abundant plaque accumulation, therefore increasing the risk of periodontal disease. Probiotic methods represent a breakthrough approach in maintaining oral health and preventing periodontal disease. Purpose: The aim of this study was to compare the effect between probiotic lozenges containing Lactobacillus reuteri and probiotic drinks containing Lactobacillus casei strain Shirota towards periodontal status of orthodontic patients. Method: Fixed orthodontic patients (n=30 from Faculty of Dentistry, Trisakti University Dental Hospital were included in this clinical trial. Periodontal status consisting of Plaque Index (PlI, Interdental Hygiene Index (HYG, and Papillary Bleeding Index (PBI were then recorded from each patient. All patients received the phase one of periodontal treatment, as well as plaque control instruction. The subjects (n=10/gp were randomly assigned to one of three groups; control group; probiotic lozenges group (Biogaia®; and probiotic drinks group (Yakult®. For 14 days, the probiotic groups were instructed to use the probiotic. Periodontal index improvement (PlI, HYG, and PBI was found in all groups after 14 days research periode. These indices were then analyzed using Kruskal-Wallis analysis test. Result: It was found that L. reuteri and L. casei strain Shirota may improve periodontal status in fixed orthodontic patients. The best results were obtained from probiotic lozenges group. However, the results were not statistically significant (p>0.05. Conclusion: It was concluded that probiotics consumption containing L. reuteri and L. casei strain Shirota may slightly improve periodontal status in fixed orthodontic patients.

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Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

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Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

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Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

Probiotics Prevent Late-Onset Sepsis in Human Milk-Fed, Very Low Birth Weight Preterm Infants: Systematic Review and Meta-Analysis.

Science.gov (United States)

Aceti, Arianna; Maggio, Luca; Beghetti, Isadora; Gori, Davide; Barone, Giovanni; Callegari, Maria Luisa; Fantini, Maria Pia; Indrio, Flavia; Meneghin, Fabio; Morelli, Lorenzo; Zuccotti, Gianvincenzo; Corvaglia, Luigi

2017-08-22

Growing evidence supports the role of probiotics in reducing the risk of necrotizing enterocolitis, time to achieve full enteral feeding, and late-onset sepsis (LOS) in preterm infants. As reported for several neonatal clinical outcomes, recent data have suggested that nutrition might affect probiotics' efficacy. Nevertheless, the currently available literature does not explore the relationship between LOS prevention and type of feeding in preterm infants receiving probiotics. Thus, the aim of this systematic review and meta-analysis was to evaluate the effect of probiotics for LOS prevention in preterm infants according to type of feeding (exclusive human milk (HM) vs. exclusive formula or mixed feeding). Randomized-controlled trials involving preterm infants receiving probiotics and reporting on LOS were included in the systematic review. Only trials reporting on outcome according to feeding type were included in the meta-analysis. Fixed-effects models were used and random-effects models were used when significant heterogeneity was found. The results were expressed as risk ratio (RR) with 95% confidence interval (CI). Twenty-five studies were included in the meta-analysis. Overall, probiotic supplementation resulted in a significantly lower incidence of LOS (RR 0.79 (95% CI 0.71-0.88), p probiotics was confirmed only in exclusively HM-fed preterm infants (RR 0.75 (95% CI 0.65-0.86), p probiotic mixtures, and not single-strain products, were effective in reducing LOS incidence (RR 0.68 (95% CI 0.57-0.80) p probiotics reduce LOS incidence in exclusively HM-fed preterm infants. Further efforts are required to clarify the relationship between probiotics supplementation, HM, and feeding practices in preterm infants.

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Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

Probiotics for the management of type 2 diabetes mellitus: A systematic review and meta-analysis.

Science.gov (United States)

Samah, Syamimi; Ramasamy, Kalavathy; Lim, Siong Meng; Neoh, Chin Fen

2016-08-01

To systematically review evidence of probiotic interventions against type 2 diabetes mellitus (T2DM) and analyse the effects of probiotics on glycaemic control among T2DM patients. Electronic search using five electronic databases was performed until October 2015. Relevant studies were identified, extracted and assessed for risk of bias. The primary outcomes of this review were glycated haemoglobin (HbA1c) and fasting blood glucose (FBG). Fasting plasma insulin, homeostasis model assessment-insulin resistance, C-reactive protein, interleukin-6 and malondialdehyde, were identified as the secondary outcomes. Mean differences (MD) between probiotics and control groups for all outcomes were pooled using either Fixed- or Random-Effect Model. Statistical heterogeneity was assessed using I(2) and Chi(2) tests. Six randomised controlled trials (RCTs) were included in the systematic review, whereas only five were included in meta-analysis. Most RCTs were presented with low or unclear risk of bias. When compared to placebo, FBG was significantly lower with probiotic consumption (MD=-0.98mmol/L; 95% CI: -1.17, 0.78, pprobiotics, with a significantly lower FBG was noted. Findings on HbA1c, anti-inflammatory and anti-oxidative effects of probiotics in the clinical setting, however, remain inconsistent. The findings imply the need for well-designed clinical studies to further assess the potential beneficial effects of probiotics in management of T2DM. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Clinical Trials

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Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

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Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

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Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

The effects of probiotics on mental health and hypothalamic-pituitary-adrenal axis: A randomized, double-blind, placebo-controlled trial in petrochemical workers.

Science.gov (United States)

Mohammadi, Ali Akbar; Jazayeri, Shima; Khosravi-Darani, Kianoush; Solati, Zahra; Mohammadpour, Nakisa; Asemi, Zatollah; Adab, Zohre; Djalali, Mahmoud; Tehrani-Doost, Mehdi; Hosseini, Mostafa; Eghtesadi, Shahryar

2016-11-01

The aim of this study was to determine effects of probiotic yogurt and multispecies probiotic capsule supplementation on mental health and hypothalamic-pituitary-adrenal axis in petrochemical workers. The present randomized double-blind, placebo-controlled trial was conducted on 70 petrochemical workers. Subjects were randomly divided into three groups to receive 100 g/day probiotic yogurt + one placebo capsule (n = 25) or one probiotic capsule daily + 100 g/day conventional yogurt (n = 25) or 100 g/day conventional yogurt + one placebo capsule (n = 20) for 6 weeks. Mental health parameters including general health questionnaire (GHQ) and depression anxiety and stress scale (DASS) scores were measured. Fasting blood samples were obtained at the beginning and 6 weeks after the intervention to quantify hypothalamic-pituitary-adrenal axis. After 6 weeks of intervention, a significant improvement of GHQ was observed in the probiotic yogurt (18.0 ± 1.5 vs. 13.5 ± 1.9, P = 0.007) and in the probiotic capsule group (16.9 ± 1.8 vs. 9.8 ± 1.9, P = 0.001), as well as a significant improvement in DASS scores in the probiotic yogurt (23.3 ± 3.7 vs. 13.0 ± 3.7, P = 0.02) and the probiotic capsule group (18.9 ± 3.2 vs. 9.4 ± 4.0, P = 0.006). However, there was no significant improvement in the conventional yogurt group (P = 0.05 for GHQ and P = 0.08 for DASS). The consumption of probiotic yogurt or a multispecies probiotic capsule had beneficial effects on mental health parameters in petrochemical workers.

Randomized, Placebo-Controlled Phase 2 Trial of a Lactobacillus crispatus Probiotic Given Intravaginally for Prevention of Recurrent Urinary Tract Infection

OpenAIRE

Stapleton, Ann E.; Au-Yeung, Melissa; Hooton, Thomas M.; Fredricks, David N.; Roberts, Pacita L.; Czaja, Christopher A.; Yarova-Yarovaya, Yuliya; Fiedler, Tina; Cox, Marsha; Stamm, Walter E.

2011-01-01

In a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic (LACTIN-VÜ, Osel, Inc.) for prevention of recurrent UTI (rUTI) in pre-menopausal women, LACTIN-V was safe, well tolerated, and associated with a reduction in rUTI.

Clinical Trials

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Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

Micronutrients, N-Acetyl Cysteine, Probiotics and Prebiotics, a Review of Effectiveness in Reducing HIV Progression

Science.gov (United States)

Hummelen, Ruben; Hemsworth, Jaimie; Reid, Gregor

2010-01-01

Low serum concentrations of micronutrients, intestinal abnormalities, and an inflammatory state have been associated with HIV progression. These may be ameliorated by micronutrients, N-acetyl cysteine, probiotics, and prebiotics. This review aims to integrate the evidence from clinical trials of these interventions on the progression of HIV. Vitamin B, C, E, and folic acid have been shown to delay the progression of HIV. Supplementation with selenium, N-acetyl cysteine, probiotics, and prebiotics has considerable potential, but the evidence needs to be further substantiated. Vitamin A, iron, and zinc have been associated with adverse effects and caution is warranted for their use. PMID:22254046

Probiotics for preventing ventilator-associated pneumonia

Science.gov (United States)

Bo, Lulong; Li, Jinbao; Tao, Tianzhu; Bai, Yu; Ye, Xiaofei; Hotchkiss, Richard S; Kollef, Marin H; Crooks, Neil H; Deng, Xiaoming

2014-01-01

Background Ventilator-associated pneumonia (VAP) is common in intensive care units (ICUs). Some evidence indicates that probiotics may reduce the incidence of VAP. Several additional published studies have demonstrated that probiotics are safe and efficacious in preventing VAP in ICUs. We aimed to systematically summarise the results of all available data to generate the best evidence for the prevention of VAP. Objectives To evaluate the effectiveness and safety of probiotics for preventing VAP. Search methods We searched CENTRAL (2014, Issue 8), MEDLINE (1948 to September week 1, 2014) and EMBASE (2010 to September 2014). Selection criteria Randomised controlled trials (RCTs) comparing probiotics with placebo or another control (excluding RCTs that use probiotics in both study groups) to prevent VAP. Data collection and analysis Two review authors independently assessed eligibility and the quality of trials, and extracted data. Main results We included eight RCTs, with 1083 participants. All studies compared a form of probiotic (Lactobacillus casei rhamnosus; Lactobacillus plantarum; Synbiotic 2000FORTE; Ergyphilus; combination Bifidobacterium longum + Lactobacillus bulgaricus + Streptococcus thermophilus) versus a control group (placebo; glutamine; fermentable fibre; peptide; chlorhexidine). The analysis of all RCTs showed that the use of probiotics decreased the incidence of VAP (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.52 to 0.95, low quality evidence). However, the aggregated results were uncertain for ICU mortality (OR 0.84, 95% CI 0.58 to 1.22 very low quality evidence), in-hospital mortality (OR 0.78, 95% CI 0.54 to 1.14, very low quality evidence), incidence of diarrhoea (OR 0.72, 95% CI 0.47 to 1.09, very low quality evidence), length of ICU stay (mean difference (MD) −1.60, 95% CI −6.53 to 3.33, very low quality evidence), duration of mechanical ventilation (MD −6.15, 95% CI −18.77 to 6.47, very low quality evidence) and antibiotic

The effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: a double-blind randomized controlled trial.

Science.gov (United States)

Kijmanawat, Athasit; Panburana, Panyu; Reutrakul, Sirimon; Tangshewinsirikul, Chayada

2018-05-20

To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet-controlled gestational diabetes mellitus. A randomized, double-blind, placebo-controlled trial was conducted between June 2016 and February 2017. Pregnant women with diet-controlled gestational diabetes mellitus were enrolled in the study at 24-28 weeks of gestation and randomized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or placebo daily for four consecutive weeks. Primary outcomes were mean differences in insulin resistance (HOMA-IR), fasting insulin and fasting plasma glucose between the two groups. Secondary outcomes were changes in maternal weight after the intervention. Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed. The changes in metabolic parameters after randomization indicated significant improvement in glucose metabolism in the probiotic group compared to the placebo group, including fasting plasma glucose (0.68 ± 5.88 vs. 4.620 ± 7.78 mg/dL, mean difference, MD, -3.94 mg/dL (95% CI -7.62, -0.27), p-value 0.034), fasting plasma insulin (1.11 ± 1.71 vs. 3.77 ± 1.70 mIU/L, MD -2.67 mIU/L (95%CI -3.57, -1.76), p-value 0.001) and HOMA-IR (0.25 ± 0.37 vs. 0.89 ± 0.46, MD -0.63 (95% CI -0.86, -0.41), p-value 0.001). Weight gain during randomization was similar between the two groups. Four weeks of probiotic supplements in women with diet-controlled gestational diabetes in the late second- and early third-trimester lowered fasting glucose and increased insulin sensitivity. Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

APPLICATION OF PROBIOTIC PRODUCT CONTAINING LACTOBACILLUS CASEI IMUNITASS IN CLINICAL PRACTICE

Directory of Open Access Journals (Sweden)

D.V. Usenko

2007-01-01

Full Text Available This article includes an overview of clinical research that study the efficiency of including into children's ration sour milk proc biotic product actimel (Danone, France, created on the basis of milk fermented with Lactobacillus bulgaricus and Streptococcus thermophilus, and enriched with culture of Lactobacillus casei DNC 114001 (commercial name L. casei imunitass.Key words: probiotic product, children, Lactobacillus casei DN 114001.

Next-Generation Probiotics Targeting Clostridium difficile through Precursor-Directed Antimicrobial Biosynthesis

Science.gov (United States)

Auchtung, Jennifer; Brown, Aaron; Boonma, Prapaporn; Oezguen, Numan; Ross, Caná L.; Luna, Ruth Ann; Runge, Jessica; Versalovic, James; Peniche, Alex; Dann, Sara M.; Britton, Robert A.; Haag, Anthony; Savidge, Tor C.

2017-01-01

probiotic efficacy in clinical trials. PMID:28760934

Synbiotics, probiotics or prebiotics in infant formula for full term infants: a systematic review.

Science.gov (United States)

Mugambi, Mary N; Musekiwa, Alfred; Lombard, Martani; Young, Taryn; Blaauw, Reneé

2012-10-04

Synbiotics, probiotics or prebiotics are being added to infant formula to promote growth and development in infants. Previous reviews (2007 to 2011) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity. This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics, probiotics or prebiotics. Cochrane methodology was followed using randomized controlled trials (RCTs) which compared term infant formula containing probiotics, prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Where appropriate, meta-analysis was performed; heterogeneity was explored using subgroup and sensitivity analyses. If studies were too diverse a narrative synthesis was provided. Three synbiotic studies (N = 475), 10 probiotics studies (N = 933) and 12 prebiotics studies (N = 1563) were included. Synbiotics failed to significantly increase growth in boys and girls. Use of synbiotics increased stool frequency, had no impact on stool consistency, colic, spitting up / regurgitation, crying, restlessness or vomiting. Probiotics in formula also failed to have any significant effect on growth, stool frequency or consistency. Probiotics did not lower the incidence of diarrhoea, colic, spitting up / regurgitation, crying, restlessness or vomiting. Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain. Prebiotics increased stool frequency but had no impact on stool consistency, the incidence of colic, spitting up / regurgitation, crying, restlessness or vomiting. There was no impact of prebiotics on the volume of formula tolerated, infections and gastrointestinal microflora. The quality of evidence was

Antibiotic treatment to prevent postextraction complications: a monocentric, randomized clinical trial. Preliminary outcomes.

Science.gov (United States)

Barone, Antonio; Marchionni, Francesco S; Cinquini, Chiara; Cipolli Panattoni, Andrea; Toti, Paolo; Marconcini, Simone; Covani, Ugo; Gabriele, Mario

2017-08-01

Tooth extraction is a very common procedure in oral surgery. Despite this, very little information is available in the literature as to the antibiotic management of the patient. The aim of this study is to evaluate whether the antibiotic prophylaxis could be beneficial in preventing postextraction local complications and whether the use of a probiotic could help reduce the antibiotic gastro-intestinal side effects. One hundred eleven patients meeting the inclusion criteria were initially included in this randomized clinical trial and randomly allocated to one of the three experimental groups according to a computer-generated randomization list. Patients allocated to the group 1 were given amoxicillin+clavulanic acid (2 g/day for 6 days), patients allocated to the group 2 received antibiotic + probiotic (Bifidobacterium longum+lactoferrin) and patients allocated to the group 3 received no antibiotic therapy after the extraction. To evaluate post-extractive complications, controls were performed at days 7, 14 and 21 after the extraction. At T1 pain at the surgical site was present in the 48%, 30% and 71.4% of the patients belonging respectively to the antibiotic alone group, to the antibiotic+probiotic group and to the control group. The mean Numeric Rating Score (NRS) score was 1.56±1.91, 1.08±1.93, 2.02±2.27 respectively (P=0.0498). Two patients belonging to the control group experienced dry socket. In addition, 9 patients (33.3%) in the antibiotic-alone group and 1 patient (2.7%) in the antibiotic+probiotic group reported intestinal distension (P=0.0012), 7 days after surgery. Finally, diarrhea was recorded in 5 patients of the antibiotic alone group (18.5%), on the other hand, no patients of the antibiotic+probiotic group and the control group reported diarrhea. Postextractive complications observed in each group have been mild and fast to resolve. The antibiotic administration showed a decrease in pain suffered by patients but a higher incidence of

Effect of probiotics (Saccharomyces boulardii) on microbial translocation and inflammation in HIV-treated patients: a double-blind, randomized, placebo-controlled trial.

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Villar-García, Judit; Hernández, Juan J; Güerri-Fernández, Robert; González, Alicia; Lerma, Elisabet; Guelar, Ana; Saenz, David; Sorlí, Lluisa; Montero, Milagro; Horcajada, Juan P; Knobel Freud, Hernando

2015-03-01

Microbial translocation has been associated with an increase in immune activation and inflammation in HIV infection despite effective highly active antiretroviral therapy. It has been shown that some probiotics have a beneficial effect by reducing intestinal permeability and, consequently, microbial translocation. To assess changes in microbial translocation and inflammation after treatment with probiotics (Saccharomyces boulardii) in HIV-1-infected patients with virologic suppression. A double-blind, randomized, placebo-controlled trial was conducted in 44 nonconsecutive HIV-1-infected patients with viral load of boulardii decreases microbial translocation (LBP) and inflammation parameters (IL-6) in HIV-1-infected patients with long-term virologic suppression.

Clinical Trials

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Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

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Microbiota and neurologic diseases: potential effects of probiotics.

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Umbrello, Giulia; Esposito, Susanna

2016-10-19

The microbiota colonizing the gastrointestinal tract have been associated with both gastrointestinal and extra-gastrointestinal diseases. In recent years, considerable interest has been devoted to their role in the development of neurologic diseases, as many studies have described bidirectional communication between the central nervous system and the gut, the so-called "microbiota-gut-brain axis". Considering the ability of probiotics (i.e., live non-pathogenic microorganisms) to restore the normal microbial population and produce benefits for the host, their potential effects have been investigated in the context of neurologic diseases. The main aims of this review are to analyse the relationship between the gut microbiota and brain disorders and to evaluate the current evidence for the use of probiotics in the treatment and prevention of neurologic conditions. Overall, trials involving animal models and adults have reported encouraging results, suggesting that the administration of probiotic strains may exert some prophylactic and therapeutic effects in a wide range of neurologic conditions. Studies involving children have mainly focused on autism spectrum disorder and have shown that probiotics seem to improve neuro behavioural symptoms. However, the available data are incomplete and far from conclusive. The potential usefulness of probiotics in preventing or treating neurologic diseases is becoming a topic of great interest. However, deeper studies are needed to understand which formulation, dosage and timing might represent the optimal regimen for each specific neurologic disease and what populations can benefit. Moreover, future trials should also consider the tolerability and safety of probiotics in patients with neurologic diseases.

Probiotics to prevent necrotising enterocolitis in very preterm infants

DEFF Research Database (Denmark)

Lambæk, Irina Dobychina; Fonnest, Gert; Gormsen, Magdalena

2016-01-01

INTRODUCTION: Meta-analyses of randomised trials have shown that probiotics reduce the risk of necrotising enterocolitis (NEC) in preterm infants. However, the generalisability of these results, particularly for the most preterm infants, remains unresolved. Hence, we wanted to evaluate the benefit...... of implementing prophylactic use of probiotics as standard care in infants younger than 30 weeks of gestation. METHODS: Two three-year periods were compared. The first period was prior to a policy change. In this period no probiotics were used. The second period featured routine administration of probiotics...... period (median six versus 14 days, p = 0.004). No side effects and no blood cultures with lactobacillus or bifidobacterium were observed. CONCLUSIONS: This historically controlled study did not indicate that probiotics had a significant effect on NEC. We continue our practice, but larger cohort studies...

Probiotics and prebiotics in ulcerative colitis.

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Derikx, Lauranne A A P; Dieleman, Levinus A; Hoentjen, Frank

2016-02-01

The intestinal microbiota is one of the key players in the etiology of ulcerative colitis. Manipulation of this microflora with probiotics and prebiotics is an attractive strategy in the management of ulcerative colitis. Several intervention studies for both the induction and maintenance of remission in ulcerative colitis patients have been performed. Most of these studies evaluated VSL#3 or E. Coli Nissle 1917 and in general there is evidence for efficacy of these agents for induction and maintenance of remission. However, studies are frequently underpowered, lack a control group, and are very heterogeneous investigating different probiotic strains in different study populations. The absence of well-powered robust randomized placebo-controlled trials impedes the widespread use of probiotics and prebiotics in ulcerative colitis. However, given the promising results that are currently available, probiotics and prebiotics may find their way to the treatment algorithm for ulcerative colitis in the near future. Copyright © 2016 Elsevier Ltd. All rights reserved.

Application of evidence on probiotics, prebiotics and synbiotics by food industry: a descriptive study.

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Mugambi, Mary N; Young, Taryn; Blaauw, Reneé

2014-10-23

This study assessed how the food industry applies the knowledge and evidence gained from synbiotics, probiotics or prebiotics research in infants, on the general paediatric population. This study also explored: what happens after the clinical trials using infant formula are completed, data is published or remains unpublished; the effectiveness and type of medium the formula manufacturers use to educate consumers on probiotic, prebiotic or synbiotic infant formula. This was a descriptive study (a survey) that used a structured questionnaire. All listed companies that manufacture and / or market food products with added probiotics, prebiotics or synbiotics for infants were identified and invited to participate. People responsible for research and development were invited to participate in the survey. A letter of invitation was sent to selected participants and if they expressed willingness to take part in the study, a questionnaire with a written consent form was sent. Descriptive statistics and associations between categorical variables were to be tested using a Chi-square test, a p food manufacturers were identified, invited to participate in the survey. No company was willing to participate in the survey for different reasons: failure to take any action 5 (20%), decision to participate indefinitely delayed 2 (8%), sensitivity of requested information 3 (12%), company does not conduct clinical trials 1 (4%), company declined without further information 4 (16%), erroneous contact information 6 (24%), refusal by receptionists to forward telephone calls to appropriate staff 3 (12%), language barrier 3 (12%), company no longer agrees to market research 1 (4%). Due to a poor response rate in this study, no conclusion could be drawn on how the food industry applies evidence gained through probiotics, prebiotics or synbiotics research on infants for the benefit of the general paediatric population. More information and greater transparency is needed from the infant

Tolerability of a probiotic in subjects with a history of methicillin-resistant Staphylococcus aureus colonisation.

Science.gov (United States)

Warrack, S; Panjikar, P; Duster, M; Safdar, N

2014-12-01

Methicillin-resistant Staphylococcus aureus (MRSA) is a pathogen of major public health importance. Colonisation precedes infection; thus reducing MRSA carriage may be of benefit for reducing infection. Probiotics represent a novel approach to reducing MRSA carriage. We undertook a pilot feasibility randomised controlled trial of the tolerability and acceptability of probiotics for reducing nasal and intestinal carriage of MRSA. In addition, subjects were screened for vancomycin-resistant enterocococci (VRE). Subjects with a history of MRSA were recruited from a large, academic medical center and randomised to take either a placebo or probiotic (Lactobacillus rhamnosus HN001). Subjects returned to the clinic after four weeks for further testing to determine adherence to the probiotic regimen and colonisation of MRSA. 48 subjects were enrolled and randomised. Nearly 25% were transplant recipients and 30% had diabetes. The probiotic was well tolerated in the study population though minor side effects, such as nausea and bloating, were observed. A majority of the subjects randomised to HN001 had good adherence to the regimen. At the four week time point among subjects randomised to the probiotic, MRSA was detected in 67 and 50% of subjects colonised in the nares and the gastrointestinal tract, respectively. Three subjects who initially tested positive for VRE were negative after four weeks of probiotic exposure. Probiotics were well tolerated in our study population of largely immunocompromised subjects with multiple comorbidities. Adherence to the intervention was good. Probiotics should be studied further for their potential to reduce colonisation by multidrug resistant bacteria.

Probiotic Amelioration of Azotemia in 5/6th Nephrectomized Sprague-Dawley Rats

Directory of Open Access Journals (Sweden)

Natarajan Ranganathan

2005-01-01

Full Text Available The present study was to test the hypothesis that selected bacteria instilled into the gastrointestinal tract could help in converting nitrogenous wastes accumulated due to renal insufficiency into nontoxic compounds; thereby, ameliorating the biochemical imbalance. Herein we describe a prospective, blinded, placebo-controlled pilot study, using 5/6th nephrectomized Sprague Dawley rat as a chronic renal failure model. The study group consisted of 36 nephrectomized and 7 non-nephrectomized (control rats. After two-week nephrectomy stabilization, cohorts of six nephrectomized rats were fed casein-based diet plus one of the following regimens: (A Control, (B Placebo (casein-based diet without probiotics, (C Bacillus pasteurii, (D Sporolac®, (E Kibow cocktail, (F CHR Hansen Cocktail, and (G ECONORMTM. Subsequently, blood (retro-orbital and urine (collected for measurements of blood urea-nitrogen and creatinine respectively, body weight and bacterial counts (feces were obtained at regular intervals. The study end-points were to determine if any of the probiotic dietary supplements facilitated, (1 decreased blood concentrations of uremic toxins, (2 altered renal function, and (3 prolonged survival. After 16 weeks of treatment, regimens C and D significantly prolonged the life span of uremic rats, in addition to showing a reduction in blood urea-nitrogen levels, concluding that supplementation of probiotic formulation to uremic rats slows the progression of azotemia, which may correlate with prolonged life span of uremic rats. Derivative trials of probiotic treatment of larger animals and humans will further assess the potential role of probiotic formulations in delaying the onset and clinical severity of clinical illness at different stages of renal failure.

Clinical Trials

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Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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Antibiotics, probiotics and prebiotics in IBD.

Science.gov (United States)

Bernstein, Charles N

2014-01-01

The dysbiosis theory of inflammatory bowel disease (IBD) posits that there is an alteration in the gut microbiome as an important underpinning of disease etiology. It stands to reason then, that administering agents that could impact on the balance of microbes on the gut could be impactful on the course of IBD. Herein is a review of the controlled trials undertaken to assess the use of antibiotics that would kill or suppress potentially injurious microbes, probiotics that would overpopulate the gut with potentially beneficial microbes or prebiotics that provide a metabolic substrate that enhances the growth of potentially beneficial microbes. With regard to antibiotics, the best data are for the use of nitroimadoles postoperatively in Crohn's disease (CD) to prevent disease recurrence. Otherwise, the data are limited with the regard to any lasting benefit of antibiotics sustaining remission in either CD or ulcerative colitis (UC). A recent meta-analysis concluded that antibiotics are superior to placebo at inducing remission in CD or UC, although the meta-analysis grouped a variety of antibiotics with different spectra of activity. Despite the absence of robust clinical trial data, antibiotics are widely used to treat perineal fistulizing CD and acute and chronic pouchitis. Probiotics have not been shown to have a beneficial role in CD. However, Escherichia coli Nissle 1917 has comparable effects to low doses of mesalamine in maintaining remission in UC. VSL#3, a combination of 8 microbes, has been shown to have an effect in inducing remission in UC and preventing pouchitis. Prebiotics have yet to be shown to have an effect in any form of IBD, but to date controlled trials have been small. The use of antibiotics should be balanced against the risks they pose. Even probiotics may pose some risk and should not be assumed to be innocuous especially when ingested by persons with a compromised epithelial barrier. Prebiotics may not be harmful but may cause

Probiotics Prevent Late-Onset Sepsis in Human Milk-Fed, Very Low Birth Weight Preterm Infants: Systematic Review and Meta-Analysis

Directory of Open Access Journals (Sweden)

Arianna Aceti

2017-08-01

Full Text Available Growing evidence supports the role of probiotics in reducing the risk of necrotizing enterocolitis, time to achieve full enteral feeding, and late-onset sepsis (LOS in preterm infants. As reported for several neonatal clinical outcomes, recent data have suggested that nutrition might affect probiotics’ efficacy. Nevertheless, the currently available literature does not explore the relationship between LOS prevention and type of feeding in preterm infants receiving probiotics. Thus, the aim of this systematic review and meta-analysis was to evaluate the effect of probiotics for LOS prevention in preterm infants according to type of feeding (exclusive human milk (HM vs. exclusive formula or mixed feeding. Randomized-controlled trials involving preterm infants receiving probiotics and reporting on LOS were included in the systematic review. Only trials reporting on outcome according to feeding type were included in the meta-analysis. Fixed-effects models were used and random-effects models were used when significant heterogeneity was found. The results were expressed as risk ratio (RR with 95% confidence interval (CI. Twenty-five studies were included in the meta-analysis. Overall, probiotic supplementation resulted in a significantly lower incidence of LOS (RR 0.79 (95% CI 0.71–0.88, p < 0.0001. According to feeding type, the beneficial effect of probiotics was confirmed only in exclusively HM-fed preterm infants (RR 0.75 (95% CI 0.65–0.86, p < 0.0001. Among HM-fed infants, only probiotic mixtures, and not single-strain products, were effective in reducing LOS incidence (RR 0.68 (95% CI 0.57–0.80 p < 0.00001. The results of the present meta-analysis show that probiotics reduce LOS incidence in exclusively HM-fed preterm infants. Further efforts are required to clarify the relationship between probiotics supplementation, HM, and feeding practices in preterm infants.

Probiotics for the Treatment of Atopic Dermatitis in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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Ruixue Huang

2017-09-01

Full Text Available Objective: Atopic dermatitis (AD is a prevalent, burdensome, and psychologically important pediatric concern. Probiotics have been suggested as a treatment for AD. Some reports have explored this topic; however, the utility of probiotics for AD remains to be firmly established.Methods: To assess the effects of probiotics on AD in children, the PubMed/Medline, Cochrane Library Scopus, and OVID databases were searched for reports published in the English language.Results: Thirteen studies were identified. Significantly higher SCORAD values favoring probiotics over controls were observed (mean difference [MD], −3.07; 95% confidence interval [CI], −6.12 to −0.03; P < 0.001. The reported efficacy of probiotics in children < 1 year old was −1.03 (95%CI, −7.05 to 4.99 and that in children 1–18 years old was −4.50 (95%CI, −7.45 to −1.54; P < 0.001. Subgroup analyses showed that in Europe, SCORAD revealed no effect of probiotics, whereas significantly lower SCORAD values were reported in Asia (MD, −5.39; 95%CI, −8.91 to −1.87. Lactobacillus rhamnosus GG (MD, 3.29; 95%CI, −0.30 to 6.88; P = 0.07 and Lactobacillus plantarum (MD, −0.70; 95%CI, −2.30 to 0.90; P = 0.39 showed no significant effect on SCORAD values in children with AD. However, Lactobacillus fermentum (MD, −11.42; 95%CI, −13.81 to −9.04, Lactobacillus salivarius (MD, −7.21; 95%CI, −9.63 to −4.78, and a mixture of different strains (MD, −3.52; 95%CI, −5.61 to −1.44 showed significant effects on SCORAD values in children with AD.Conclusions: Our meta-analysis indicated that the research to date has not robustly shown that probiotics are beneficial for children with AD. However, caution is needed when generalizing our results, as the populations evaluated were heterogeneous. Randomized controlled trials with larger samples and greater power are necessary to identify the species, dose, and treatment duration of probiotics that are most efficacious

Clinical Trials

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Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

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Probiotics

Science.gov (United States)

Reid, Gregor; Hammond, Jo-Anne

2005-01-01

OBJECTIVE To define the term probiotics, to indicate how to identify products that have been proven beneficial, and to assess the quality of evidence regarding probiotics. QUALITY OF EVIDENCE A few level I studies support the effectiveness of specific probiotics for certain diagnoses. For most so-called probiotics, however, weak or no evidence supports their effectiveness. MAIN MESSAGE Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Level I evidence supports use of VSL#3 for maintaining remission of inflammatory colitis. Probiotics for treating vaginal infections, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, have level I evidence of effectiveness, but are not available in Canada. Specific probiotics taken for certain indications improve health and have few side effects. CONCLUSION Limited but good evidence supports the role of certain probiotics in medical practice. Because consumer pressure will undoubtedly stimulate further interest in probiotics, family doctors need to be informed about them so they can advise their patients appropriately. PMID:16353831

Influence of Acute Multispecies and Multistrain Probiotic Supplementation on Cardiovascular Function and Reactivity to Psychological Stress in Young Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.

Science.gov (United States)

Möller, Clara M; Olsa, Eamon J A; Ginty, Annie T; Rapelje, Alyssa L; Tindall, Christina L; Holesh, Laura A; Petersen, Karen L; Conklin, Sarah M

2017-10-01

The potential influence of probiotic supplementation on cardiovascular health and stress responsivity remains largely unexplored. Some evidence suggests the possibility that probiotics may influence blood pressure. A separate body of research suggests that exaggerated cardiovascular reactions to acute psychological stress in the laboratory predict cardiovascular morbidity and mortality. The current investigation explored the effect of acute probiotic use on (1) resting cardiovascular measures in healthy young adults and (2) cardiovascular and psychological reactions to an acute psychological stressor in the laboratory. Participants (N = 105, M [SD] age = 20.17 [1.26], 84.8% white) completed a 2-week, double-blind, and placebo-controlled trial of a multispecies and multistrain probiotic. Exclusion criteria included previous probiotic use, diagnosed gastrointestinal disorder, and/or current antibiotic use. At visits 1 and 2, participants completed the Paced Auditory Serial Addition Test, a widely used psychological stress task. Participants were randomly assigned to a probiotic blend or matched placebo. Compared with placebo, 2-week probiotic supplementation did not affect resting measures of cardiovascular function, cardiovascular responses during or recovery from stress, or psychological reactions to acute psychological stress. Contrary to expectations, short-term use of a probiotic supplement in healthy participants did not influence measures of cardiovascular function or responsivity to psychological stress. Future research is needed to determine species- and strain-specific effects of probiotics in healthy participants with various degrees of stress responsiveness, as well as in diseased populations.

Understanding Clinical Trials

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Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

Clinical Trials

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Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

Towards a compatible probiotic-antibiotic combination therapy: assessment of antimicrobial resistance in the Japanese probiotics.

Science.gov (United States)

Hammad, A M; Shimamoto, T

2010-10-01

To determine the antimicrobial resistance of the Japanese probiotics available in the market without a pharmacist's supervision. A total of 43 isolates were obtained from 40 samples of probiotics (30 dairy products and 10 products in tablet form). Isolates were identified using 16S rRNA gene sequencing and tested for their susceptibility to 14 antimicrobials. They were screened using PCR for some antibiotic resistance genes. Inactivation of cefepime, clarithromycin and vancomycin by different inocula of 11 strains was evaluated using the antibiotic inactivation bioassay. None of the dairy probiotics showed a level of constitutive resistance or carried inducible resistance genes, making them suitable to be administrated with macrolides. Among the probiotics in tablet form only Enterococcus faecium strains carrying the msrC gene showed an MIC(90) of 4 μg ml(-1). Extended-spectrum β-lactams, tetracyclines and ampicillin exhibited powerful germicidal activity against the vast majority of the probiotic strains. There is a limited choice of the Japanese probiotics that can be administered with clinically used antibiotics. Japanese probiotics are widely distributed all over the world. Through the findings of our study, we have attempted to provide guidance for clinicians interested in using the Japanese probiotics in combination with antibiotics. © 2010 The Authors. Journal compilation © 2010 The Society for Applied Microbiology.

Long-term safety and efficacy of perinatal probiotic intervention: Evidence from a follow-up study of four randomized, double-blind, placebo-controlled trials.

Science.gov (United States)

Lundelin, Krista; Poussa, Tuija; Salminen, Seppo; Isolauri, Erika

2017-03-01

Societies worldwide are faced with a progressive increase in immune-mediated health problems such as allergic, autoimmune, and inflammatory diseases, as well as obesity. Perinatal administration of specific probiotic bacteria is an attractive approach in reducing the risk of these conditions, but long-term efficacy and safety data are lacking. The aim here was to evaluate the clinical benefit and long-term safety of specific probiotics administered during the perinatal period. The probiotic strains used were Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb-12, Lactobacillus paracasei ST11, and Bifidobacterium longum BL999. The children involved have subsequently undergone prospective long-term follow-up. In addition to physical examination, data were collected by structured questionnaires on non-communicable diseases and continued probiotic use, and growth data from welfare clinics and school nurses. Altogether 303 mother-infant pairs were included in the analysis. Seventy-six of 163 (47%) children receiving perinatal probiotics had developed allergic disease compared with 79 of 140 (56%) receiving placebo (OR 0.67, 95% confidence intervals [CI] 0.43-1.06, p = 0.09). Fifty-nine of 133 (44%) children receiving L. rhamnosus GG perinatally had developed allergic disease, OR 0.62, 95% CI 0.38-0.99, p = 0.047, as compared to placebo. We found no differences in growth or non-communicable disease prevalence between children receiving perinatally probiotics or placebo. Perinatal probiotic administration is safe in long-term follow-up. Children receiving L. rhamnosus GG perinatally tended to have decreased allergy prevalence. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

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Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

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Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

Probiotic Soy Product Supplemented with Isoflavones Improves the Lipid Profile of Moderately Hypercholesterolemic Men: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Daniela Cardoso Umbelino Cavallini

2016-01-01

Full Text Available Background: Cardiovascular disease is the leading cause of worldwide morbidity and mortality. Several studies have demonstrated that specific probiotics affect the host’s metabolism and may influence the cardiovascular disease risk. Objectives: The aim of this study was to investigate the influence of an isoflavone-supplemented soy product fermented with Enterococcus faecium CRL 183 and Lactobacillus helveticus 416 on cardiovascular risk markers in moderately hypercholesterolemic subjects. Design: Randomized placebo-controlled double-blind trial Setting: São Paulo State University in Araraquara, SP, Brazil. Participants: 49 male healthy men with total cholesterol (TC >5.17 mmol/L and <6.21 mmol/L Intervention: The volunteers have consumed 200 mL of the probiotic soy product (group SP-1010 CFU/day, isoflavone-supplemented probiotic soy product (group ISP–probiotic plus 50 mg of total isoflavones/100 g or unfermented soy product (group USP-placebo for 42 days in a randomized, double-blind study. Main outcome measures: Lipid profile and additional cardiovascular biomarkers were analyzed on days 0, 30 and 42. Urine samples (24 h were collected at baseline and at the end of the experiment so as to determine the isoflavones profile. Results: After 42 days, the ISP consumption led to improved total cholesterol, non-HDL-C (LDL + IDL + VLDL cholesterol fractions and electronegative LDL concentrations (reduction of 13.8%, 14.7% and 24.2%, respectively, p < 0.05. The ISP and SP have prevented the reduction of HDL-C level after 42 days. The C-reactive protein and fibrinogen levels were not improved. The equol production by the ISP group subjects was inversely correlated with electronegative LDL concentration. Conclusions: The results suggest that a regular consumption of this probiotic soy product, supplemented with isoflavones, could contribute to reducing the risk of cardiovascular diseases in moderately hypercholesterolemic men, through the an

Using omics and integrated multi-omics approaches to guide probiotic selection to mitigate chytridiomycosis and other emerging infectious diseases

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Eria Alaide Rebollar

2016-02-01

Full Text Available Emerging infectious diseases in wildlife are responsible for massive population declines. In amphibians, chytridiomycosis caused by Batrachochytrium dendrobatidis, Bd, has severely affected many amphibian populations and species around the world. One promising management strategy is probiotic bioaugmentation of antifungal bacteria on amphibian skin. In vivo experimental trials using bioaugmentation strategies have had mixed results, and therefore a more informed strategy is needed to select successful probiotic candidates. Metagenomic, transcriptomic, and metabolomic methods, colloquially called omics, are approaches that can better inform probiotic selection and optimize selection protocols. The integration of multiple omic data using bioinformatic and statistical tools and in silico models that link bacterial community structure with bacterial defensive function can allow the identification of species involved in pathogen inhibition. We recommend using 16S rRNA gene amplicon sequencing and methods such as indicator species analysis, the K-S Measure, and co-occurrence networks to identify bacteria that are associated with pathogen resistance in field surveys and experimental trials. In addition to 16S amplicon sequencing, we recommend approaches that give insight into symbiont function such as shotgun metagenomics, metatranscriptomics or metabolomics to maximize the probability of finding effective probiotic candidates, which can then be isolated in culture and tested in persistence and clinical trials. An effective mitigation strategy to ameliorate chytridiomycosis and other emerging infectious diseases is necessary; the advancement of omic methods and the integration of multiple omic data provide a promising avenue toward conservation of imperiled species.

Synbiotics, probiotics or prebiotics in infant formula for full term infants: a systematic review

Directory of Open Access Journals (Sweden)

Mugambi Mary N

2012-10-01

Full Text Available Abstract Background Synbiotics, probiotics or prebiotics are being added to infant formula to promote growth and development in infants. Previous reviews (2007 to 2011 on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity. This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics, probiotics or prebiotics. Methods Cochrane methodology was followed using randomized controlled trials (RCTs which compared term infant formula containing probiotics, prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants. The mean difference (MD and corresponding 95% confidence intervals (CI were reported for continuous outcomes, risk ratio (RR and corresponding 95% CI for dichotomous outcomes. Where appropriate, meta-analysis was performed; heterogeneity was explored using subgroup and sensitivity analyses. If studies were too diverse a narrative synthesis was provided. Results Three synbiotic studies (N = 475, 10 probiotics studies (N = 933 and 12 prebiotics studies (N = 1563 were included. Synbiotics failed to significantly increase growth in boys and girls. Use of synbiotics increased stool frequency, had no impact on stool consistency, colic, spitting up / regurgitation, crying, restlessness or vomiting. Probiotics in formula also failed to have any significant effect on growth, stool frequency or consistency. Probiotics did not lower the incidence of diarrhoea, colic, spitting up / regurgitation, crying, restlessness or vomiting. Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain. Prebiotics increased stool frequency but had no impact on stool consistency, the incidence of colic, spitting up / regurgitation, crying, restlessness or vomiting. There was no impact of prebiotics on the volume of formula tolerated, infections and gastrointestinal

Probiotic, Prebiotic, and Brain Development

Directory of Open Access Journals (Sweden)

Tomás Cerdó

2017-11-01

Full Text Available Recently, a number of studies have demonstrated the existence of a link between the emotional and cognitive centres of the brain and peripheral functions through the bi-directional interaction between the central nervous system and the enteric nervous system. Therefore, the use of bacteria as therapeutics has attracted much interest. Recent research has found that there are a variety of mechanisms by which bacteria can signal to the brain and influence several processes in relation to neurotransmission, neurogenesis, and behaviour. Data derived from both in vitro experiments and in vivo clinical trials have supported some of these new health implications. While recent molecular advancement has provided strong indications to support and justify the role of the gut microbiota on the gut–brain axis, it is still not clear whether manipulations through probiotics and prebiotics administration could be beneficial in the treatment of neurological problems. The understanding of the gut microbiota and its activities is essential for the generation of future personalized healthcare strategies. Here, we explore and summarize the potential beneficial effects of probiotics and prebiotics in the neurodevelopmental process and in the prevention and treatment of certain neurological human diseases, highlighting current and future perspectives in this topic.

Probiotics, Prebiotics & Food allergy Prevention: Clinical Data in Children.

Science.gov (United States)

Fiocchi, Alessandro; Pecora, Valentina; Dahdah, Lamia

2016-07-01

there are accruing evidences on the role of the intestinal microbiota in the development of allergic diseases among infants. Elaborating on this theoretical basis, studies did assess the possibilities to prevent allergic diseases in infancy through manipulation of the intestinal microbiota. We review here such studies. interventional studies led to conflicting conclusions on the possible role of probiotics and prebiotics in allergy prevention. Two metanalyses published in 2015 did reconcile all data. Guidelines have been predicated on such studies using the GRADE methodology. the guidelines for allergy prevention suggest for the first time the use of probiotics and prebiotics. The existing evidences stand for a use of such supplementation in particular for the prevention of eczema. As there is no evidence so far of superiority of one probiotic strand over the others, they should be considered as class and not as individual products.

The use of a probiotic in captive cheetahs (Acinonyx jubatus

Directory of Open Access Journals (Sweden)

K.N. Koeppel

2006-06-01

Full Text Available Juvenile captive cheetahs (Acinonyx jubatus often present with diarrhoea that is commonly associated with bacterial infections. A species-specific probiotic containing Lactobacillus Group 2 and Enterococcus faecium was prepared from healthy adult cheetahs. Juvenile cheetahs (n = 27 between 8 and 13 months of age were included in the probiotic trial. The animals were observed prior to and after feeding of the probiotic which was made available for 28 days. Feeding of the probiotic resulted in a significantly increased body weight in the treatment group (P = 0.026, while there was no increase in the control group. A relative improvement in the faecal quality in the probiotic group during the treatment period compared with the pre-treatment (P = 0.0363 and post-treatment (P = 0.004 period was observed. This was accompanied by an absence of blood and mucus in the faeces during the treatment period in the probiotic group.

Clinical Trials

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Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

Systematic review with meta-analysis: the efficacy of probiotics in inflammatory bowel disease.

Science.gov (United States)

Derwa, Y; Gracie, D J; Hamlin, P J; Ford, A C

2017-08-01

Ulcerative colitis (UC) and Crohn's disease (CD) are inflammatory bowel diseases (IBD). Evidence implicates disturbances of the gastrointestinal microbiota in their pathogenesis. To perform a systematic review and meta-analysis to examine the efficacy of probiotics in IBD. MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched (until November 2016). Eligible randomised controlled trials (RCTs) recruited adults with UC or CD, and compared probiotics with 5-aminosalicylates (5-ASAs) or placebo. Dichotomous symptom data were pooled to obtain a relative risk (RR) of failure to achieve remission in active IBD, or RR of relapse of disease activity in quiescent IBD, with 95% confidence intervals (CIs). The search identified 12 253 citations. Twenty-two RCTs were eligible. There was no benefit of probiotics over placebo in inducing remission in active UC (RR of failure to achieve remission=0.86; 95% CI=0.68-1.08). However, when only trials of VSL#3 were considered there appeared to be a benefit (RR=0.74; 95% CI=0.63-0.87). Probiotics appeared equivalent to 5-ASAs in preventing UC relapse (RR=1.02; 95% CI=0.85-1.23). There was no benefit of probiotics in inducing remission of active CD, in preventing relapse of quiescent CD, or in preventing relapse of CD after surgically induced remission. VSL#3 may be effective in inducing remission in active UC. Probiotics may be as effective as 5-ASAs in preventing relapse of quiescent UC. The efficacy of probiotics in CD remains uncertain, and more evidence from RCTs is required before their utility is known. © 2017 John Wiley & Sons Ltd.

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Dietary supplementation with probiotics during late pregnancy: outcome on vaginal microbiota and cytokine secretion

Directory of Open Access Journals (Sweden)

Vitali Beatrice

2012-10-01

Full Text Available Abstract Background The vaginal microbiota of healthy women consists of a wide variety of anaerobic and aerobic bacterial genera and species dominated by the genus Lactobacillus. The activity of lactobacilli helps to maintain the natural healthy balance of the vaginal microbiota. This role is particularly important during pregnancy because vaginal dismicrobism is one of the most important mechanisms for preterm birth and perinatal complications. In the present study, we characterized the impact of a dietary supplementation with the probiotic VSL#3, a mixture of Lactobacillus, Bifidobacterium and Streptococcus strains, on the vaginal microbiota and immunological profiles of healthy women during late pregnancy. Results An association between the oral intake of the probiotic VSL#3 and changes in the composition of the vaginal microbiota of pregnant women was revealed by PCR-DGGE population profiling. Despite no significant changes were found in the amounts of the principal vaginal bacterial populations in women administered with VSL#3, qPCR results suggested a potential role of the probiotic product in counteracting the decrease of Bifidobacterium and the increase of Atopobium, that occurred in control women during late pregnancy. The modulation of the vaginal microbiota was associated with significant changes in some vaginal cytokines. In particular, the decrease of the anti-inflammatory cytokines IL-4 and IL-10 was observed only in control women but not in women supplemented with VSL#3. In addition, the probiotic consumption induced the decrease of the pro-inflammatory chemokine Eotaxin, suggesting a potential anti-inflammatory effect on the vaginal immunity. Conclusion Dietary supplementation with the probiotic VSL#3 during the last trimester of pregnancy was associated to a modulation of the vaginal microbiota and cytokine secretion, with potential implications in preventing preterm birth. Trial registration ClinicalTrials.gov NCT01367470

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Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults.

LENUS (Irish Health Repository)

Quigley, Eamonn M M

2012-04-01

For decades, if not centuries, a variety of products with what would now be regarded as prebiotic and probiotic properties have been consumed by the general public and advocated for their benefits on health and, in particular, gastrointestinal well-being. More recently, medical science has taken a great interest in the population of micro-organisms, the gut microbiota that normally populates the human gut, and the range of important functions carried out by the microbiota in health is being progressively defined. As a corollary, the list of disorders and diseases that may result from disruption of the normal microbiota and\\/or its interaction with the host continues to grow. A scientific basis for the use of probiotics and prebiotics is, therefore, beginning to emerge. Unfortunately, although progress has been made, the clinical evidence to support the use of these preparations lags behind. Nevertheless, a number of human disease states may benefit from the use of probiotics, most notably, diarrheal illnesses, some inflammatory bowel diseases, certain infectious disorders, and irritable bowel syndrome. Prebiotics promote the growth of "good" bacteria, and although a variety of health benefits have been attributed to their use, prebiotics have been subjected to few large-scale clinical trials.

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Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

Efficacy and safety of the probiotic Saccharomyces boulardii for the prevention and therapy of gastrointestinal disorders

Science.gov (United States)

Kelesidis, Theodoros

2012-01-01

Several clinical trials and experimental studies strongly suggest a place for Saccharomyces boulardii as a biotherapeutic agent for the prevention and treatment of several gastrointestinal diseases. S. boulardii mediates responses resembling the protective effects of the normal healthy gut flora. The multiple mechanisms of action of S. boulardii and its properties may explain its efficacy and beneficial effects in acute and chronic gastrointestinal diseases that have been confirmed by clinical trials. Caution should be taken in patients with risk factors for adverse events. This review discusses the evidence for efficacy and safety of S. boulardii as a probiotic for the prevention and therapy of gastrointestinal disorders in humans. PMID:22423260

[Use of probiotics in bacterial vaginosis].

Science.gov (United States)

Mur Pérez, A M; Mateo Segura, Z; Ramírez Domínguez, N; Vela Condón, P

Bacterial vaginosis (BV) is a change in the vaginal microbiota due to bacterial overgrowth of normal microorganisms, which produces symptoms of vaginal discomfort, increased malodorous vaginal discharge, etc. Although they been seen to improve recurrence rates in clinical practice, the role of probiotics is questioned in these situations. A literature review on BV is presented in order to evaluate the effectiveness of using probiotics as adjuvant therapy in BV. PubMed, Cochrane and SCOPUS review of the last 5 years publications using probiotics to treat women diagnosed with BV. An analysis was performed on the 10 items that refer to the use of probiotics in addition to antibiotic treatments. All items conclude that the use of probiotics is beneficial in cases of BV in addition to conventional treatments. However, the conclusions are not categorical due to there being a wide variety of studies and probiotics used. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

Probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2) improve rhinoconjunctivitis-specific quality of life in individuals with seasonal allergies: a double-blind, placebo-controlled, randomized trial.

Science.gov (United States)

Dennis-Wall, Jennifer C; Culpepper, Tyler; Nieves, Carmelo; Rowe, Cassie C; Burns, Alyssa M; Rusch, Carley T; Federico, Ashton; Ukhanova, Maria; Waugh, Sheldon; Mai, Volker; Christman, Mary C; Langkamp-Henken, Bobbi

2017-03-01

Background: Rhinoconjunctivitis-specific quality of life is often reduced during seasonal allergies. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MRQLQ) is a validated tool used to measure quality of life in people experiencing allergies (0 = not troubled to 6 = extremely troubled). Probiotics may improve quality of life during allergy season by increasing the percentage of regulatory T cells (Tregs) and inducing tolerance. Objective: The objective of this study was to determine whether consuming Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and B. longum MM-2 compared with placebo would result in beneficial effects on MRQLQ scores throughout allergy season in individuals who typically experience seasonal allergies. Secondary outcomes included changes in immune markers as part of a potential mechanism for changes in MRQLQ scores. Design: In this double-blind, placebo-controlled, parallel, randomized clinical trial, 173 participants (mean ± SEM: age 27 ± 1 y) who self-identified as having seasonal allergies received either a probiotic (2 capsules/d, 1.5 billion colony-forming units/capsule) or placebo during spring allergy season for 8 wk. MRQLQ scores were collected weekly throughout the study. Fasting blood samples were taken from a subgroup (placebo, n = 37; probiotic, n = 35) at baseline and week 6 (predicted peak of pollen) to determine serum immunoglobulin (Ig) E concentrations and Treg percentages. Results: The probiotic group reported an improvement in the MRQLQ global score from baseline to pollen peak (-0.68 ± 0.13) when compared with the placebo group (-0.19 ± 0.14; P = 0.0092). Both serum total IgE and the percentage of Tregs increased from baseline to week 6, but changes were not different between groups. Conclusions: This combination probiotic improved rhinoconjunctivitis-specific quality of life during allergy season for healthy individuals with self-reported seasonal allergies; however, the associated mechanism is

Effects of probiotics on the recurrence of bacterial vaginosis: a review.

Science.gov (United States)

Homayouni, Aziz; Bastani, Parvin; Ziyadi, Somayeh; Mohammad-Alizadeh-Charandabi, Sakineh; Ghalibaf, Morad; Mortazavian, Amir Mohammad; Mehrabany, Elnaz Vaghef

2014-01-01

Bacterial vaginosis (BV) is a common cause of genital discomfort in women in reproductive ages, which causes many complications. Bacterial vaginosis is usually treated by metronidazole and clindamycin. However, this protocol does not prevent its recurrence, which is a main complaint of the patients. The number of lactobacilli in the vagina of women with BV is significantly lower than that in healthy women. Hence, efforts have been made to normalize vaginal flora by oral or vaginal administration of lactobacilli. The objective of the present study was to review clinical evidences available regarding the efficacy of probiotics in the prevention and treatment of BV. Published randomized controlled trials were searched in PubMed, Science Direct, and the Cochrane Database between 1990 and 2011. Search terms included bacterial vaginosis, urinary tract infection, lactobacillus, and probiotics. Orally consumed probiotics are believed to ascend to the vaginal tract after they are excreted from the rectum; vaginal administration allows for direct replacement of the probiotics for unhealthy vaginal microbiota and occupation of specific adhesion sites at the epithelial surface of the urinary tract, which consequently results in maintenance of a low pH and production of antimicrobial substances like acids and hydrogen peroxide. Receiving Lactobacillus acidophilus, Lactobacillus rhamnosus GR-1, and Lactobacillus fermentum RC-14 at a dose of at least 10 CFU/day for 2 months has been shown to present the patients with better results. Although the results of different studies are controversial, most studies have been in favor of the probiotics in the prevention or treatment of BV, and no adverse effects have been reported. Therefore, it may be helpful to recommend daily consumption of probiotic products to improve public health among women.

Conducting clinical trials in Singapore.

Science.gov (United States)

Woo, K T

1999-04-01

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Probiotics in inflammatory bowel disease--therapeutic rationale and role.

LENUS (Irish Health Repository)

Shanahan, Fergus

2012-02-03

The intestinal flora has a conditioning effect on intestinal homeostasis, delivering regulatory signals to the epithelium, the mucosal immune system and to the neuromuscular activity of the gut. Beneficial metabolic activities of the enteric flora include nutrient production, metabolism of dietary carcinogens, conversion of prodrugs to active drugs. However, increasing evidence suggests that some components of the enteric flora are essential ingredients in the pathogenesis of inflammatory bowel disease (IBD); this has prompted interest in therapeutic manipulation of the flora with probiotics. Probiotics are biologic control agents-described as live microbial food supplements which confer a health benefit beyond inherent basic nutrition. Multiple potential beneficial effects have been attributed to the probiotic use of lactic acid bacteria, bifidobacteria and other non-pathogenic commensals. At present, much of the promise of probiotics remains outside the realm of evidence-based medicine and awaits the results of prospective trials, now underway. No reliable in vitro predictors of in vivo efficacy of putative probiotics have been identified. Rigorous comparisons of probiotic performance have not been performed and the suitability of a given probiotic for different individuals is largely unexplored. Notwithstanding, an improved understanding of the normal commensal flora and host-flora interactions has the potential to open up new therapeutic strategies for inflammatory disorders of the gut.

Clinical Trials

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Probiotics, prebiotics and colorectal cancer prevention.

Science.gov (United States)

Ambalam, Padma; Raman, Maya; Purama, Ravi Kiran; Doble, Mukesh

2016-02-01

Colorectal cancer (CRC), the third major cause of mortality among various cancer types in United States, has been increasing in developing countries due to varying diet and dietary habits and occupational hazards. Recent evidences showed that composition of gut microbiota could be associated with the development of CRC and other gut dysbiosis. Modulation of gut microbiota by probiotics and prebiotics, either alone or in combination could positively influence the cross-talk between immune system and microbiota, would be beneficial in preventing inflammation and CRC. In this review, role of probiotics and prebiotics in the prevention of CRC has been discussed. Various epidemiological and experimental studies, specifically gut microbiome research has effectively improved the understanding about the role of probiotics and microbial treatment as anticarcinogenic agents. A few human studies support the beneficial effect of probiotics and prebiotics; hence, comprehensive understanding is urgent to realize the clinical applications of probiotics and prebiotics in CRC prevention. Copyright © 2016 Elsevier Ltd. All rights reserved.

Improved Helicobacter pylori Eradication Rate of Tailored Triple Therapy by Adding Lactobacillus delbrueckii and Streptococcus thermophilus in Northeast Region of Thailand: A Prospective Randomized Controlled Clinical Trial

Directory of Open Access Journals (Sweden)

Taweesak Tongtawee

2015-01-01

Full Text Available Background and Aim. To evaluate the effect of Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus to Helicobacter pylori eradication in different periods of therapeutic protocol. Methods. Infected patients were randomized to one-week tailored triple therapy (esomeprazole 20 mg bid, clarithromycin 500 mg bid/metronidazole 400 mg tid if clarithromycin resistant, and amoxicillin 1000 mg bid with placebo (group 1, n=100; one week of pretreatment with probiotics (group 2, n=100; and one week of pretreatment with probiotic followed by one week of the same probiotics after treatment (group 3, n=100. Result. PP analysis involved 292 patients, 98 in group 1, 97 in group 2, and 97 in group 3. Successful eradication was observed in 229 patients; by PP analysis, the eradication rates were significantly higher (P<0.01, 95% CI; 0.71–0.97 in group 2 and group 3 than group 1. ITT analysis eradication rates were significantly higher in group 2 and group 3 than group 1 (P<0.01 95% CI; 0.72–0.87, and there is no significant difference between the three groups (P=0.32 in terms of adverse events. Conclusion. Adding probiotics before or before and after tailored treatment can improve Helicobacter pylori eradication rates. This trial is registered with Thai Clinical Trials Registry number: TCTR20141209001.

Improved Helicobacter pylori Eradication Rate of Tailored Triple Therapy by Adding Lactobacillus delbrueckii and Streptococcus thermophilus in Northeast Region of Thailand: A Prospective Randomized Controlled Clinical Trial.

Science.gov (United States)

Tongtawee, Taweesak; Dechsukhum, Chavaboon; Leeanansaksiri, Wilairat; Kaewpitoon, Soraya; Kaewpitoon, Natthawut; Loyd, Ryan A; Matrakool, Likit; Panpimanmas, Sukij

2015-01-01

Background and Aim. To evaluate the effect of Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus to Helicobacter pylori eradication in different periods of therapeutic protocol. Methods. Infected patients were randomized to one-week tailored triple therapy (esomeprazole 20 mg bid, clarithromycin 500 mg bid/metronidazole 400 mg tid if clarithromycin resistant, and amoxicillin 1000 mg bid) with placebo (group 1, n=100); one week of pretreatment with probiotics (group 2, n=100); and one week of pretreatment with probiotic followed by one week of the same probiotics after treatment (group 3, n=100). Result. PP analysis involved 292 patients, 98 in group 1, 97 in group 2, and 97 in group 3. Successful eradication was observed in 229 patients; by PP analysis, the eradication rates were significantly higher (P<0.01, 95% CI; 0.71-0.97) in group 2 and group 3 than group 1. ITT analysis eradication rates were significantly higher in group 2 and group 3 than group 1 (P<0.01 95% CI; 0.72-0.87), and there is no significant difference between the three groups (P=0.32) in terms of adverse events. Conclusion. Adding probiotics before or before and after tailored treatment can improve Helicobacter pylori eradication rates. This trial is registered with Thai Clinical Trials Registry number: TCTR20141209001.

Probiotic research in Australia, New Zealand and the Asia-Pacific region.

Science.gov (United States)

Crittenden, R; Bird, A R; Gopal, P; Henriksson, A; Lee, Y K; Playne, M J

2005-01-01

Although the epicentres of probiotic research in the past decade have been Japan and Europe, researchers in the Asia-Pacific region have actively contributed to the growing understanding of the intestinal microbial ecosystem, and interactions between gut bacteria, diet and health of the human host. A number of new probiotic strains have been developed in the region that have been demonstrated to have beneficial impacts on health in animal and human trials, including improved protection against intestinal pathogens and modulation of the immune system. Probiotics targeted to animals, including aquaculture, feature heavily in many Asian countries. Developments in probiotic technologies have included microencapsulation techniques, antimicrobial production in fermented meats, and synbiotic combinations. In particular, the impact of resistant starch on the intestinal environment and fermentation by intestinal bacteria has been intensively studied and new probiotic strains selected specifically for synbiotic combinations with resistant starch. This paper provides an overview of probiotic research within Australia, New Zealand and a number of Asian countries, and lists scientists in the Asia-Pacific region involved in various aspects of probiotic research and development.

Recurrent urinary tract infections in women: How promising is the use of probiotics?

Science.gov (United States)

Gupta, Varsha; Nag, Deepika; Garg, Pratibha

2017-01-01

Urinary tract infections (UTIs) currently rank amongst the most prevalent bacterial infections, representing a major health hazard. UTIs in females usually start as vaginal infections and ascend to the urethra and bladder. Recurrent UTIs (rUTIs) can be defined as at least three episodes of UTI in 1 year or two episodes in 6 months. Various antibiotics have been the mainstay of therapy in ameliorating the incidence of UTIs, but recurrent infections continue to afflict many women. It necessitates the exploitation of alternative antimicrobial therapy. Probiotics have been shown to be effective in varied clinical trials for long-term preventions of rUTI. Because Escherichia coli is the primary pathogen involved in UTIs which spreads from the rectum to vagina and then ascends up the sterile urinary tract, improving the gut or vaginal flora will thus impact the urinary tract. Since a healthy vaginal microbiota is mainly dominated by Lactobacillus species, in this context, exogenously administered probiotics containing Lactobacilli play a pivotal role in reducing the risk of rUTI. The concept of artificially boosting the Lactobacilli numbers through probiotic administration has long been conceived but has been recently shown to be possible. Lactobacilli may especially be useful for women with a history of recurrent, complicated UTIs or on prolonged antibiotic use. Probiotics do not cause antibiotic resistance and may offer other health benefits due to vaginal re-colonisation with Lactobacilli. However, more comprehensive research is still needed, to recommend for probiotics as an alternative to antibiotics.

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Presence of Lactobacillus reuteri in saliva coincide with higher salivary IgA in young adults after intake of probiotic lozenges

DEFF Research Database (Denmark)

Braathen, G; Ingildsen, V; Twetman, S

2017-01-01

The aim of this study was to compare the concentration of salivary immunoglobulin A (IgA) and the selected interleukins (IL)-1β, IL-6, IL-8 and IL-10 in young individuals with presence and non-presence of Lactobacillus reuteri in saliva after a three-week intervention with probiotic lozenges. The...... to interpret and understand their possible immune-modulating role in maintaining oral health........ The study group consisted of 47 healthy individuals aged 18-32 years with no clinical signs of oral inflammation. In a randomised, double-blind, placebo-controlled, cross-over trial participants ingested two lozenges per day containing two strains of the probiotic bacterium L. reuteri or placebo lozenges......, detectable levels of L. reuteri in saliva coincided with higher concentrations of salivary IgA and %IgA/protein in stimulated whole saliva after the three-week daily intake of probiotic lozenges. Our findings suggest that monitoring the presence of probiotic candidates in the oral environment is important...

Properties of probiotics and encapsulated probiotics in food.

Science.gov (United States)

Ozyurt, V Hazal; Ötles, Semih

2014-01-01

Probiotics are microorganisms which confer health benefits upon application in sufficiently-high viable cell amounts. Probiotics are typically members of Lactobacillus and Bifidobacterium species commonly associated with human gastrointestinal tracts. In the recent past, there has been a rising interest in producing functional foods containing encapsulated probiotic bacteria. Recent studies have been reported using dairy products like cheese, yogurt and ice cream as food carrier, and non-dairy products like meat, fruits, cereals, chocolate, etc. However, the industrial sector contains only few encapsulated probiotic products. Probiotics have been developed by several companies in a capsule or a tablet form. The review compiles probiotics, encapsulation technology and cell life in the food matrices.

Probiotics and Time to Achieve Full Enteral Feeding in Human Milk-Fed and Formula-Fed Preterm Infants: Systematic Review and Meta-Analysis.

Science.gov (United States)

Aceti, Arianna; Gori, Davide; Barone, Giovanni; Callegari, Maria Luisa; Fantini, Maria Pia; Indrio, Flavia; Maggio, Luca; Meneghin, Fabio; Morelli, Lorenzo; Zuccotti, Gianvincenzo; Corvaglia, Luigi

2016-07-30

Probiotics have been linked to a reduction in the incidence of necrotizing enterocolitis and late-onset sepsis in preterm infants. Recently, probiotics have also proved to reduce time to achieve full enteral feeding (FEF). However, the relationship between FEF achievement and type of feeding in infants treated with probiotics has not been explored yet. The aim of this systematic review and meta-analysis was to evaluate the effect of probiotics in reducing time to achieve FEF in preterm infants, according to type of feeding (exclusive human milk (HM) vs. formula). Randomized-controlled trials involving preterm infants receiving probiotics, and reporting on time to reach FEF were included in the systematic review. Trials reporting on outcome according to type of feeding (exclusive HM vs. formula) were included in the meta-analysis. Fixed-effect or random-effects models were used as appropriate. Results were expressed as mean difference (MD) with 95% confidence interval (CI). Twenty-five studies were included in the systematic review. In the five studies recruiting exclusively HM-fed preterm infants, those treated with probiotics reached FEF approximately 3 days before controls (MD -3.15 days (95% CI -5.25/-1.05), p = 0.003). None of the two studies reporting on exclusively formula-fed infants showed any difference between infants receiving probiotics and controls in terms of FEF achievement. The limited number of included studies did not allow testing for other subgroup differences between HM and formula-fed infants. However, if confirmed in further studies, the 3-days reduction in time to achieve FEF in exclusively HM-fed preterm infants might have significant implications for their clinical management.

The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial.

Science.gov (United States)

Palacios, Talia; Vitetta, Luis; Coulson, Samantha; Madigan, Claire D; Denyer, Gareth S; Caterson, Ian D

2017-01-09

Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus. Sixty adults with a body mass index ≥25 kg/m 2 with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment. Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications. Australian New Zealand Clinical Trials Registry, ACTRN12613001378718 . Registered on 16 December 2013.

Clinical Trials

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Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

Clinical Trials

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Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

Clinical Trials

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Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

Clinical Trials

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Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

Probiotics in digestive diseases: focus on Lactobacillus GG.

Science.gov (United States)

Pace, F; Pace, M; Quartarone, G

2015-12-01

Probiotics are becoming increasingly important in basic and clinical research, but they are also a subject of considerable economic interest due to their expanding popularity. They are live micro-organisms which, when administered in adequate amounts, confer a health benefit to the host. From this very well-known definition, it is clear that, unlike drugs, probiotics might be useful in healthy subjects to reduce the risk of developing certain diseases or to optimise some physiological functions. They also may offer some advantages in already ill persons in relieving symptoms and signs, e.g. people with acute diarrhea. According to current definitions, probiotics should survive both gastric acid and bile to reach the small intestine and colon, where they exert their effects. Many of these are available in a lyophilized (freeze-dried) pill form, though some are available in yogurt or as packets (sachets), which can be mixed into non-carbonated drinks. The present review focuses on three main issues: 1) understanding why, at present, probiotics are so interesting for doctors and consumers; 2) reviewing the available data on probiotic use in digestive diseases, in particular irritable bowel syndrome (IBS), (prevention of) infectious diarrhea, inflammatory bowel disease (IBD), non-alcoholic fatty liver disease (NAFLD), and colorectal cancer (CRC); 3) highlighting the individual profile of Lactobacillus GG (LGG) in the above contexts, providing an assessment as well as recommendations on its use in gastro-intestinal tract (GIT) disorders. Research studies conducted in animals and humans with the main probiotics strains for GIT diseases, and published from the early 1990s to 2014 have been considered. PubMed, Medline and Ovid were the main sources adopted for data retrieving. The increasing attention on probiotics is a direct consequence of the improvement in the techniques for studying microbiota. Until recently, its composition has been analysed by culture-based methods

Probiotics are helpful in hepatic encephalopathy: a meta-analysis of randomized trials.

Science.gov (United States)

Saab, Sammy; Suraweera, Duminda; Au, Jennifer; Saab, Elena G; Alper, Tori S; Tong, Myron J

2016-07-01

Hepatic encephalopathy (HE) is a major complication of cirrhosis and is associated with decreased survival and increased health care utilization. The aim of this study was to evaluate the efficacy of probiotics in the management minimal hepatic encephalopathy HE (MHE) and overt HE (OHE) in comparison to no treatment/placebo and lactulose. The main outcomes measured were mortality, improvement in MHE, progression to OHE in patients with MHE and hospitalization. We calculated odds ratios (OR) with 95% confidence intervals (CI). Study heterogeneity was assessed using the I(2) statistic. Fourteen studies totalling 1152 patients were included in the analysis. The use of probiotics had no impact on the overall mortality when compared to either lactulose (OR: 1.07, 95% CI: 0.47-2.44, P = 0.88) or no treatment/placebo (OR: 0.69, 95% CI: 0.42-1.14, P = 0.15). When probiotics was compared to no treatment/placebo, it was associated with a significant improvement in MHE (OR: 3.91, 95% CI: 2.25-6.80, P probiotics did not show a significant difference in improvement of MHE (OR: 0.81, 95% CI: 0.52-1.27, P = 0.35), hospitalization rates (OR: 1.02, 95% CI: 0.52-1.99, P = 0.96) or progression to overt hepatic encephalopathy (OR: 1.24, 95% CI 0.73-2.10, P = 0.42). Overall the use of probiotics was more effective in decreasing hospitalization rates, improving MHE and preventing progression to OHE in patients with underlying MHE than placebo, but similar to that seen with lactulose. The use of probiotics did not affect mortality rates. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Cytokine and clinical response to Saccharomyces boulardii therapy in diarrhea-dominant irritable bowel syndrome: a randomized trial.

Science.gov (United States)

Abbas, Zaigham; Yakoob, Javed; Jafri, Wasim; Ahmad, Zubair; Azam, Zahid; Usman, Muhammad W; Shamim, Sara; Islam, Muhammad

2014-06-01

This preliminary study aimed to investigate the effects of the probiotic Saccharomyces boulardii on proinflammatory and anti-inflammatory cytokines in patients with diarrhea-dominant irritable bowel syndrome (IBS-D). The other objectives were to document any clinical improvement as judged by symptoms, quality of life, and histology. This was a randomized, double blind, placebo-controlled trial in which S. boulardii, 750 mg/day, or placebo was administered for 6 weeks in IBS-D patients, in addition to ispaghula husk standard treatment. Thirty-seven patients received S. boulardii and 35 patients received the placebo. As compared with placebo, the S. boulardii group showed a significant decrease in blood and tissue levels of proinflammatory cytokines interleukin-8 (IL-8) and tumor necrosis factor-α (PS. boulardii group. Although baseline histological findings were mild, an improvement was observed in the probiotic group in the lymphocyte and neutrophil infiltrates (P=0.017 and 0.018), epithelial mitosis (P=0.003), and intraepithelial lymphocytes (P=0.024). No serious adverse events were found in either group. S. boulardii with ispaghula husk was superior to placebo with ispaghula husk in improving the cytokine profile, histology, and quality of life of patients with IBS-D. These preliminary results need to be confirmed in a well-powered trial.

Managing clinical trials

Directory of Open Access Journals (Sweden)

Kenyon Sara

2010-07-01

Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

Efficacy and safety of the probiotic Lactobacillus paracasei LP-33 in allergic rhinitis

DEFF Research Database (Denmark)

Costa, D J; Marteau, P; Amouyal, M

2014-01-01

BACKGROUND/OBJECTIVES: An imbalance between Th1 and Th2 cells is involved in allergic rhinitis (AR) that may be improved by probiotics. To test the efficacy of the probiotic Lactobacillus paracasei subsp. paracasei LP-33, a double-blind, placebo-controlled, randomized trial was carried out in pat...

Probiotics Supplementation Therapy for Pathological Neonatal Jaundice: A Systematic Review and Meta-Analysis.

Science.gov (United States)

Chen, Zhe; Zhang, Lingli; Zeng, Linan; Yang, Xiaoyan; Jiang, Lucan; Gui, Ge; Zhang, Zuojie

2017-01-01

Background: Neonatal jaundice is a relatively prevalent disease and affects approximately 2.4-15% newborns. Probiotics supplementation therapy could assist to improve the recovery of neonatal jaundice, through enhancing immunity mainly by regulating bacterial colonies. However, there is limited evidence regarding the effect of probiotics on bilirubin level in neonates. Therefore, this study aims at systematically evaluating the efficacy and safety of probiotics supplement therapy for pathological neonatal jaundice. Methods: Databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Database (Wan Fang), Chinese Biomedical Literature Database (CBM), VIP Database for Chinese Technical Periodicals (VIP) were searched and the deadline is December 2016. Randomized controlled trials (RCTs) of probiotics supplementation for pathological neonatal jaundice in publications were extracted by two reviewers. The cochrane tool was applied to assessing the risk of bias of the trials. The extracted information of RCTs should include efficacy rate, serum total bilirubin level, time of jaundice fading, duration of phototherapy, duration of hospitalization, adverse reactions. The main outcomes of the trials were analyzed by Review Manager 5.3 software. The relative risks (RR) or mean difference (MD) with a 95% confidence interval (CI) was used to measure the effect. Results: 13 RCTs involving 1067 neonatal with jaundice were included in the meta-analysis. Probiotics supplementation treatment showed efficacy [RR: 1.19, 95% CI (1.12, 1.26), P jaundice. It not only decreased the total serum bilirubin level after 3day [MD: -18.05, 95% CI (-25.51, -10.58), P jaundice fading [MD: -1.91, 95% CI (-2.06, -1.75), P probiotics supplementation therapy is an effective and safe treatment for pathological neonatal jaundice.

Fundamentals of clinical trials

CERN Document Server

Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

2015-01-01

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

Probiotics for Gastrointestinal Conditions: A Summary of the Evidence.

Science.gov (United States)

Wilkins, Thad; Sequoia, Jacqueline

2017-08-01

Probiotics contain microorganisms, most of which are bacteria similar to the beneficial bacteria that occur naturally in the human gut. Probiotics have been widely studied in a variety of gastrointestinal diseases. The most-studied species include Lactobacillus, Bifidobacterium, and Saccharomyces. However, a lack of clear guidelines on when to use probiotics and the most effective probiotic for different gastrointestinal conditions may be confusing for family physicians and their patients. Probiotics have an important role in the maintenance of immunologic equilibrium in the gastrointestinal tract through the direct interaction with immune cells. Probiotic effectiveness can be species-, dose-, and disease-specific, and the duration of therapy depends on the clinical indication. There is high-quality evidence that probiotics are effective for acute infectious diarrhea, antibiotic-associated diarrhea, Clostridium difficile- associated diarrhea, hepatic encephalopathy, ulcerative colitis, irritable bowel syndrome, functional gastrointestinal disorders, and necrotizing enterocolitis. Conversely, there is evidence that probiotics are not effective for acute pancreatitis and Crohn disease. Probiotics are safe for infants, children, adults, and older patients, but caution is advised in immunologically vulnerable populations.

Effect of Probiotic Lactobacillus reuteri on Salivary Cariogenic Bacterial Counts among Groups of Preschool Children in Jeddah, Saudi Arabia: A Randomized Clinical Trial.

Science.gov (United States)

Alamoudi, Najlaa M; Almabadi, Eman S; El Ashiry, Eman A; El Derwi, Douaa A

2018-05-15

To evaluate the effect of probiotic Lactobacilli reuteri lozenges on caries-associated salivary bacterial counts (Mutans streptococci and Lactobacillus), dental plaque accumulation, and salivary buffer capacity in a group of preschool children. The study group consisted of 178 healthy children (aged 3-6 years). Children were randomly grouped: the experimental group (n = 90) received L. reuteri probiotic lozenges and the control group (n = 88) received placebo lozenges, twice daily, for 28 days. Salivary Mutans streptococci and Lactobacillus counts, and buffer capacity were assessed using chair-side caries-risk test (CRT®) kits. The Simplified Oral Hygiene index (OHI-S) was used to assess dental plaque accumulation at baseline and after 28 days. After 28 days, the experimental group had a statistically significant reduction in Mutans streptococci and lactobacilli (p = 0.000 and p = 0.020, respectively) and both groups had less plaque accumulation than at baseline. While the buffer capacity in the experimental group increased more than in the control group, it was not statistically significant (p = 0.577). Compliance was 90%, with no adverse events. Consumption of probiotic lozenges containing L. reuteri reduces caries-associated bacterial counts significantly. Probiotics consumption may have a beneficial caries-preventive effect.

Effects of probiotics supplement in patients with type 2 diabetes mellitus: A meta-analysis of randomized trials.

Science.gov (United States)

Hu, Yi-Meng; Zhou, Feng; Yuan, Yin; Xu, Yan-Cheng

2017-04-21

To objectively evaluate the effects of probiotics supplement on glycemic control and lipid metabolism in patients with type 2 diabetes mellitus (T2DM). The randomized controlled trials (RCTs) with regard to the probiotics or synbiotics for the treatment of T2DM were collected through retrieving 5 databases from their establishment to March 2016. After study selection, quality assessment and data extraction were performed by 2 authors independently; and STATA software was used for statistical analysis. The level of evidence was evaluated by applying the GRADE system. Twelve RCTs involving 770 participants were enrolled. The results of the meta-analysis showed that probiotics could significantly reduce fasting blood glucose by -11.27mg/dL (95% CI -21.76 to -0.79; PProbiotics could significantly reduce HOMA-IR of T2DM patients (-1.05; 95% CI -1.52 to -0.59; Pprobiotics on total cholesterol (-8.49mg/dL; 95% CI -15.24 to -1.73; P=.014) and triglycerides (TG; -23.66mg/dL; 95% CI -40.26 to -7.05; Pprobiotics had stronger reduction effect on serum insulin concentration (-3.32μU/mL; 95% CI -5.89 to-0.75; P=.001) and TG (-25.94mg/dL; 95% CI -65.33 to 13.44; Pprobiotics can improve glucose control and lipid metabolism. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Clinical trial methodology

National Research Council Canada - National Science Library

Peace, Karl E; Chen, Ding-Geng

2011-01-01

"Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

Effect of Micronutrient and Probiotic Fortified Yogurt on Immune-Function of Anti-Retroviral Therapy Naive HIV Patients  

Directory of Open Access Journals (Sweden)

J. Dik F. Habbema

2011-10-01

Full Text Available Background: Micronutrient supplementation has been shown to reduce the progression of HIV but does not have an effect on the intestinal barrier or the intestinal microbiota of HIV patients. Studies have suggested that probiotics could potentially complement micronutrients in preserving the immune-function of HIV patients. Objective: Assess the impact of micronutrient supplemented probiotic yogurt on the immune function of HIV patients. Design: We performed a randomized, double blind, controlled trial with CD4 count as primary outcome among HIV patients naïve to anti-retroviral treatment. Secondary outcomes included hematological parameters, incidence of diarrhea and clinical symptoms. A total of 112 HIV patients were randomized to receive a micronutrient fortified yogurt with (n = 55 or without additional probiotic Lactobacillus rhamnosus GR-1 (n = 57 for four weeks. Results: An average decline in CD4 count of −70 cells/μL (95% CI: −154 to −15 was observed in the micronutrient, probiotic group versus a decrease of −63 cells/μL (95% CI: −157 to −30 in the micronutrient control group (p = 0.9. Additional probiotic supplementation was well tolerated and not associated with adverse events. No difference between groups was detected in incidence of diarrhea or clinical symptoms. An improvement of hemoglobin levels was observed for all subjects, based upon a mean difference from baseline of 1.4 g/L (SD = 6 (p = 0.02. Conclusion: The addition of probiotics to a micronutrient fortified yogurt was well tolerated by HIV patients but was not associated with a further increase in CD4 count after one month.

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

Science.gov (United States)

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

Effects of a food enriched with probiotics on Streptococcus mutans and Lactobacillus spp. salivary counts in preschool children: a cluster randomized trial.

Science.gov (United States)

Villavicencio, Judy; Villegas, Lina Maria; Arango, Maria Cristina; Arias, Susana; Triana, Francia

2018-05-14

Probiotics have provided benefits to general health, but they are still insufficient to dental health. This study aimed to evaluate milk supplemented with probiotic bacteria and standard milk, measured by levels of Streptococcus mutans (S. mutans) and Lactobacillus spp., in 3-4-year-old children after 9 months of intervention. The study was a triple-blind, placebo-controlled, randomized trial. The sample was composed of 363 preschoolers attending five child development centers in Cali, Colombia. They were randomized to two groups: children in the intervention group drank 200 mL of milk with Lactobacillus rhamnosus 5x106 and Bifidobacteruim longum 3x106, and children in the control group drank 200 mL of standard milk. Interventions occurred on weekdays and information was gathered through scheduled clinical examination. The primary result was the number of colony forming units (CFU) of S. mutans and Lactobacillus spp. in the saliva. Secondary results were dental caries, rated by the International Caries Detection and Assessment System (ICDAS), dental plaque, pH, and salivary buffer capacity. The proportion of S. mutans was lower in the intervention group compared with the control group after 9 months; however, the differences did not reach statistical significance (p=0.173); on the other hand, statistically significant differences between groups were found in the CFU/mL of Lactobacillus spp. (p=0.002). There was not statistically significant difference in the prevalence of dental caries for both groups (p=0.767). Differences between groups were found in the salivary buffering capacity (p=0.000); neither salivary pH nor dental plaque were significantly different. Regular consumption of milk containing probiotics bacteria reduced CFU/mL of Lactobacillus spp. and increased salivary buffering capacity at 9 months of consumption.

Probiotics: definition, sources, selection, and uses.

Science.gov (United States)

Sanders, Mary Ellen

2008-02-01

Interest in probiotics is at an all-time high in the United States, driven in part by new products emerging in the market, by US researchers eager to evaluate efficacy claims rigorously, and by consumers interested in potential therapeutic and preventive health benefits. The US marketplace is a mixed bag of products, some well-defined and properly evaluated in controlled clinical studies and others with unsubstantiated claims of efficacy. Validation of probiotic contents in commercial products is needed to ensure consumer confidence. The term "probiotic" should be used only for products that meet the scientific criteria for this term-namely, products that contain an adequate dose of live microbes that have been documented in target-host studies to confer a health benefit. Probiotics must be identified to the level of strain, must be characterized for the specific health target, and must be formulated into products using strains and doses shown to be efficacious. Several characteristics commonly presumed to be essential to probiotics, such as human origin and the ability to improve the balance of the intestinal microbiota, are discussed.

Probiotics and Atopic Dermatitis: An Overview

Directory of Open Access Journals (Sweden)

Irfan A. Rather

2016-04-01

Full Text Available Atopic dermatitis (AD is a common, recurrent, chronic inflammatory skin disease that is a cause of considerable economic and social burden. Its prevalence varies substantially among different countries with an incidence rate proclaimed to reach up to 20% of children in developed countries and continues to escalate in developing nations. This increased rate of incidence has changed the focus of research on AD toward epidemiology, prevention, and treatment. The effects of probiotics in the prevention and treatment of AD remain elusive. However, evidence from different research groups show that probiotics could have positive effect on AD treatment, if any, that depend on multiple factors, such as specific probiotic strains, time of administration (onset time, duration of exposure, and dosage. However, till date we still lack strong evidence to advocate the use of probiotics in the treatment of AD, and questions remain to be answered considering its clinical use in future. Based on updated information, the processes that facilitate the development of AD and the topic of the administration of probiotics are addressed in this review.

Seven cases of Saccharomyces fungaemia related to use of probiotics.

Science.gov (United States)

Roy, Ujjwayini; Jessani, Laxman G; Rudramurthy, Shivaprakash M; Gopalakrishnan, Ram; Dutta, Soma; Chakravarty, Chandrashish; Jillwin, Joseph; Chakrabarti, Arunaloke

2017-06-01

Probiotics are increasingly used in critically ill patients without enough safety data. The aim of the present study was to determine the association of probiotics with Saccharomyces cerevisiae fungaemia. Seven patients with S. cerevisiae fungaemia were reported at two hospitals in India between July 2014 and September 2015. Detailed clinical history of patients was recorded. Besides the seven patient isolates, three probiotics sachets used in those patients and five unrelated clinical isolates were used for association study by Fluorescent amplified fragment length polymorphism (FAFLP). Antifungal susceptibility testing was performed by broth microdilution technique of CLSI (M27-A3) and interpreted according to CLSI (M27S4). Two patients were premature neonates and five were adults. They were admitted in intensive care unit and were on probiotics containing S. boulardii (except one adult patient). FAFLP analysis showed 96.4-99.7% similarity between blood and corresponding probiotic isolates. Of the three AFLP types (group I, II, II) identified, all the probiotic isolates clustered in group I (major cluster) including majority of the blood isolates. The isolates were susceptible to all antifungal agents tested. Five patients, who could be evaluated, responded promptly to echinocandins or voriconazole. As the prescription of probiotic containing S. boulardii in critically ill patient's leads to the fungaemia, we recommend avoiding this probiotic in those patients. © 2017 Blackwell Verlag GmbH.

Timely Use of Probiotics in Hospitalized Adults Prevents Clostridium difficile Infection: A Systematic Review With Meta-Regression Analysis.

Science.gov (United States)

Shen, Nicole T; Maw, Anna; Tmanova, Lyubov L; Pino, Alejandro; Ancy, Kayley; Crawford, Carl V; Simon, Matthew S; Evans, Arthur T

2017-06-01

Systematic reviews have provided evidence for the efficacy of probiotics in preventing Clostridium difficile infection (CDI), but guidelines do not recommend probiotic use for prevention of CDI. We performed an updated systematic review to help guide clinical practice. We searched MEDLINE, EMBASE, International Journal of Probiotics and Prebiotics, and The Cochrane Library databases for randomized controlled trials evaluating use of probiotics and CDI in hospitalized adults taking antibiotics. Two reviewers independently extracted data and assessed risk of bias and overall quality of the evidence. Primary and secondary outcomes were incidence of CDI and adverse events, respectively. Secondary analyses examined the effects of probiotic species, dose, timing, formulation, duration, and study quality. We analyzed data from 19 published studies, comprising 6261 subjects. The incidence of CDI in the probiotic cohort, 1.6% (54 of 3277), was lower than of controls, 3.9% (115 of 2984) (P probiotic users was 0.42 (95% confidence interval, 0.30-0.57; I 2  = 0.0%). Meta-regression analysis demonstrated that probiotics were significantly more effective if given closer to the first antibiotic dose, with a decrement in efficacy for every day of delay in starting probiotics (P = .04); probiotics given within 2 days of antibiotic initiation produced a greater reduction of risk for CDI (relative risk, 0.32; 95% confidence interval, 0.22-0.48; I 2  = 0%) than later administration (relative risk, 0.70; 95% confidence interval, 0.40-1.23; I 2  = 0%) (P = .02). There was no increased risk for adverse events among patients given probiotics. The overall quality of the evidence was high. In a systematic review with meta-regression analysis, we found evidence that administration of probiotics closer to the first dose of antibiotic reduces the risk of CDI by >50% in hospitalized adults. Future research should focus on optimal probiotic dose, species, and formulation. Systematic

Probiotics and the urologist.

Science.gov (United States)

Bruce, Andrew W; Reid, Gregor

2003-04-01

Emerging from the stigma of once being referred to as "snake oil", excellent scientific and clinical evidence now exists to indicate that probiotics do indeed have a role to play in medicine. The proper definition of probiotics is important "Live microorganisms which when administered in adequate amounts confer a health benefit on the host", for several reasons. It rules out so-called probiotics that have no clinically proven, peer-reviewed data, and it states the need to have viable bacteria present, unlike these pseudo products which are often wrongly labeled, poorly manufactured, with low or no viability at time of use. Guidelines, prepared by the United Nations and World Health Organization are now available to guide physicians and consumers as to the types of strains with documented benefits. In urology, the most studied strains are Lactobacillus rhamnosus GR-1 and L. fermentum B-54 and RC-14. Their use daily in oral form, or once to three times weekly as a vaginal suppository, have been shown to reduce the urogenital pathogen load and the risk of urinary tract and vaginal infections. Organisms such as Oxalobacter formigenes, still in the R&D phase, offer great potential to reduce kidney stone formation via oxalate degradation in the intestine. Some studies using L. casei Shirota suggest a possible effect against bladder cancer, while studies using L. plantarum 299 show significantly reduced infection rates in patients undergoing major surgical procedures. In short, specific probiotic strains hold much promise for use in the urology setting.

Recurrent urinary tract infections in women: How promising is the use of probiotics?

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Varsha Gupta

2017-01-01

Full Text Available Urinary tract infections (UTIs currently rank amongst the most prevalent bacterial infections, representing a major health hazard. UTIs in females usually start as vaginal infections and ascend to the urethra and bladder. Recurrent UTIs (rUTIs can be defined as at least three episodes of UTI in 1 year or two episodes in 6 months. Various antibiotics have been the mainstay of therapy in ameliorating the incidence of UTIs, but recurrent infections continue to afflict many women. It necessitates the exploitation of alternative antimicrobial therapy. Probiotics have been shown to be effective in varied clinical trials for long-term preventions of rUTI. Because Escherichia coli is the primary pathogen involved in UTIs which spreads from the rectum to vagina and then ascends up the sterile urinary tract, improving the gut or vaginal flora will thus impact the urinary tract. Since a healthy vaginal microbiota is mainly dominated by Lactobacillus species, in this context, exogenously administered probiotics containing Lactobacilli play a pivotal role in reducing the risk of rUTI. The concept of artificially boosting the Lactobacilli numbers through probiotic administration has long been conceived but has been recently shown to be possible. Lactobacilli may especially be useful for women with a history of recurrent, complicated UTIs or on prolonged antibiotic use. Probiotics do not cause antibiotic resistance and may offer other health benefits due to vaginal re-colonisation with Lactobacilli. However, more comprehensive research is still needed, to recommend for probiotics as an alternative to antibiotics.

Probiotics and infantile atopic eczema

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Akelma AZ

2015-09-01

Full Text Available Ahmet Zülfikar Akelma,1 Aziz Alper Biten2 1Pediatric Allergy and Immunology Unit, Ankara Kecioren Teaching and Research Hospital, Ankara, Turkey; 2General Directorate of Management Services, Republic of Turkey Ministry of Health, Ankara, Turkey Abstract: Pediatric eczema is a common disease which causes economic and social burden. Its incidence differs among the societies, with an incidence reported to reach up to 20% in developed countries. Eczema is the first allergic disease seen in the childhood, and it is recognized as a precursor for the development of atopic diseases such as asthma, allergic rhinitis, and food allergy in the forthcoming years of children. Increased incidence of eczema in recent years has led to new research in epidemiology, prevention, and intervention of this disease. It is no doubt important to treat itching, rash, and excoriation of the skin; however, treatment of pediatric eczema should not be considered only as a treatment of skin lesions. Considering skin treatment as the tip of the iceberg, proper management of the allergic processes can be accepted as the rest of the iceberg. The role of probiotics in the prevention of atopic eczema is yet to be clarified. Evidence presented by existing studies suggesting that probiotics may prevent pediatric eczema is not strong enough. A positive effect, if any, may be related with onset time, dose, duration, and use of specific probiotics. To date, there is no strong evidence for use of probiotics in the treatment of eczema; however, administration of probiotics in breast-feeding mothers in the prenatal period and in infants in the postnatal period can be accepted as a safe and helpful option in the prevention of eczema. Nevertheless, there are still questions to be answered in the future about probiotic administration for eczema. Clinical use of probiotics will gradually become more widespread when these questions are answered. Based on current information, the administration

Disrupted intestinal microbiota and intestinal inflammation in children with cystic fibrosis and its restoration with Lactobacillus GG: a randomised clinical trial.

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Eugenia Bruzzese

Full Text Available Intestinal inflammation is a hallmark of cystic fibrosis (CF. Administration of probiotics can reduce intestinal inflammation and the incidence of pulmonary exacerbations. We investigated the composition of intestinal microbiota in children with CF and analyzed its relationship with intestinal inflammation. We also investigated the microflora structure before and after Lactobacillus GG (LGG administration in children with CF with and without antibiotic treatment.The intestinal microbiota were analyzed by denaturing gradient gel electrophoresis (DGGE, real-time polymerase chain reaction (RT-PCR, and fluorescence in situ hybridization (FISH. Intestinal inflammation was assessed by measuring fecal calprotectin (CLP and rectal nitric oxide (rNO production in children with CF as compared with healthy controls. We then carried out a small double-blind randomized clinical trial with LGG.Twenty-two children with CF children were enrolled in the study (median age, 7 years; range, 2-9 years. Fecal CLP and rNO levels were higher in children with CF than in healthy controls (184±146 µg/g vs. 52±46 µg/g; 18±15 vs. 2.6±1.2 µmol/L NO2 (-, respectively; P<0.01. Compared with healthy controls, children with CF had significantly different intestinal microbial core structures. The levels of Eubacterium rectale, Bacteroides uniformis, Bacteroides vulgatus, Bifidobacterium adolescentis, Bifidobacterium catenulatum, and Faecalibacterium prausnitzii were reduced in children with CF. A similar but more extreme pattern was observed in children with CF who were taking antibiotics. LGG administration reduced fecal CLP and partially restored intestinal microbiota. There was a significant correlation between reduced microbial richness and intestinal inflammation.CF causes qualitative and quantitative changes in intestinal microbiota, which may represent a novel therapeutic target in the treatment of CF. Administration of probiotics restored gut microbiota, supporting

Prebiotics, probiotics, synbiotics, and the immune system: experimental data and clinical evidence.

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Frei, Remo; Akdis, Mübeccel; O'Mahony, Liam

2015-03-01

The intestinal immune system is constantly exposed to foreign antigens, which for the most part should be tolerated. Certain probiotics, prebiotics, and synbiotics are able to influence immune responses. In this review, we highlight the recent publications (within the last 2 years) that have substantially progressed this field. The immunological mechanisms underpinning probiotics, prebiotics, and synbiotics effects continue to be better defined with novel mechanisms being described for dendritic cells, epithelial cells, T regulatory cells, effector lymphocytes, natural killer T cells, and B cells. Many of the mechanisms being described are bacterial strain or metabolite specific, and should not be extrapolated to other probiotics or prebiotics. In addition, the timing of intervention seems to be important, with potentially the greatest effects being observed early in life. In this review, we discuss the recent findings relating to probiotics, prebiotics, and synbiotics, specifically their effects on immunological functions.

Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial.

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Judit Villar-García

Full Text Available Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP and systemic inflammation (IL-6 in 44 HIV virologically suppressed patients, half of whom (n = 22 had immunologic non-response to antiretroviral therapy (<270 CD4+Tcells/μL despite long-term suppressed viral load. The aim of the present study was to investigate if this beneficial effect of the probiotic Saccharomyces boulardii is due to modified gut microbiome composition, with a decrease of some species associated with higher systemic levels of microbial translocation and inflammation. In this study, we used 16S rDNA gene amplification and parallel sequencing to analyze the probiotic impact on the composition of the gut microbiome (faecal samples in these 44 patients randomized to receive oral supplementation with probiotic or placebo for 12 weeks. Compared to the placebo group, in individuals treated with probiotic we observed lower concentrations of some gut species, such as those of the Clostridiaceae family, which were correlated with systemic levels of bacterial translocation and inflammation markers. In a sub-study of these patients, we observed significantly higher parameters of microbial translocation (LBP, soluble CD14 and systemic inflammation in immunologic non-responders than in immunologic responders, which was correlated with a relative abundance of specific gut bacterial groups (Lachnospiraceae genus and Proteobacteria. Thus, in this work, we propose

Probiotics as oral health biotherapeutics.

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Saha, Shyamali; Tomaro-Duchesneau, Catherine; Tabrizian, Maryam; Prakash, Satya

2012-09-01

Oral health is affected by its resident microorganisms. Three prominent oral disorders are dental caries, gingivitis and periodontitis, with the oral microbiota playing a key role in the initiation/progression of all three. Understanding the microbiota and the diseases they may cause is critical to the development of new therapeutics. This review is focused on probiotics for the prevention and/or treatment of oral diseases. This review describes the oral ecosystem and its correlation with oral health/disease. The pathogenesis and current prevention/treatment strategies of periodontal diseases (PD) and dental caries (DC) are depicted. An introduction of probiotics is followed by an analysis of their role in PD and DC, and their potential role(s) in oral health. Finally, a discussion ensues on the future research directions and limitations of probiotics for oral health. An effective oral probiotic formulation should contribute to the prevention/treatment of microbial diseases of the oral cavity. Understanding the oral microbiota's role in oral disease is important for the development of a therapeutic to prevent/treat dental diseases. However, investigations into clinical efficacy, delivery/dose optimization, mechanism(s) of action and other related parameters are yet to be fully explored. Keeping this in mind, investigations into oral probiotic therapies are proving promising.

Cholesterol-Lowering Probiotics as Potential Biotherapeutics for Metabolic Diseases

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Manoj Kumar

2012-01-01

Full Text Available Cardiovascular diseases are one of the major causes of deaths in adults in the western world. Elevated levels of certain blood lipids have been reported to be the principal cause of cardiovascular disease and other disabilities in developed countries. Several animal and clinical trials have shown a positive association between cholesterol levels and the risks of coronary heart disease. Current dietary strategies for the prevention of cardiovascular disease advocate adherence to low-fat/low-saturated-fat diets. Although there is no doubt that, in experimental conditions, low-fat diets offer an effective means of reducing blood cholesterol concentrations on a population basis, these appear to be less effective, largely due to poor compliance, attributed to low palatability and acceptability of these diets to the consumers. Due to the low consumer compliance, attempts have been made to identify other dietary components that can reduce blood cholesterol levels. Supplementation of diet with fermented dairy products or lactic acid bacteria containing dairy products has shown the potential to reduce serum cholesterol levels. Various approaches have been used to alleviate this issue, including the use of probiotics, especially Bifidobacterium spp. and Lactobacillus spp.. Probiotics, the living microorganisms that confer health benefits on the host when administered in adequate amounts, have received much attention on their proclaimed health benefits which include improvement in lactose intolerance, increase in natural resistance to infectious disease in gastrointestinal tract, suppression of cancer, antidiabetic, reduction in serum cholesterol level, and improved digestion. In addition, there are numerous reports on cholesterol removal ability of probiotics and their hypocholesterolemic effects. Several possible mechanisms for cholesterol removal by probiotics are assimilation of cholesterol by growing cells, binding of cholesterol to cellular surface

Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial

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Villar-Garc?a, Judit; G?erri-Fern?ndez, Robert; Moya, Andr?s; Gonz?lez, Alicia; Hern?ndez, Juan J.; Lerma, Elisabet; Guelar, Ana; Sorli, Luisa; Horcajada, Juan P.; Artacho, Alejandro; D?Auria, Giuseppe; Knobel, Hernando

2017-01-01

Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly ...

Acid production in dental plaque after exposure to probiotic bacteria

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Keller Mette K

2012-10-01

Full Text Available Abstract Background The increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli on plaque lactic acid (LA production in vitro and in vivo. Methods In the first part (A, suspensions of two lactobacilli strains (L. reuteri DSM 17938, L. plantarum 299v were added to suspensions of supragingival dental plaque collected from healthy young adults (n=25. LA production after fermentation with either xylitol or fructose was analyzed. In the second part (B, subjects (n=18 were given lozenges with probiotic lactobacilli (L. reuteri DSM 17938 and ATCC PTA 5289 or placebo for two weeks in a double-blinded, randomized cross-over trial. The concentration of LA in supragingival plaque samples was determined at baseline and after 2 weeks. Salivary counts of mutans streptococci (MS and lactobacilli were estimated with chair-side methods. Results Plaque suspensions with L. reuteri DSM 17938 produced significantly less LA compared with L. plantarum 299v or controls (p Conclusion Lactic acid production in suspensions of plaque and probiotic lactobacilli was strain-dependant and the present study provides no evidence of an increase in plaque acidity by the supply of selected probiotic lactobacilli when challenged by fructose or xylitol. The study protocol was approved by The Danish National Committee on Biomedical Research Ethics (protocol no H-2-2010-112. Trial registration NCT01700712

Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial.

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De Lorenzo, Antonino; Costacurta, Micaela; Merra, Giuseppe; Gualtieri, Paola; Cioccoloni, Giorgia; Marchetti, Massimiliano; Varvaras, Dimitrios; Docimo, Raffaella; Di Renzo, Laura

2017-06-10

Evidence of probiotics effects on gut function, brain activity and emotional behaviour were provided. Probiotics can have dramatic effects on behaviour through the microbiome-gut-brain axis, through vagus nerve. We investigated whether chronic probiotic intake could modulate psychological state, eating behaviour and body composition of normal weight obese (NWO) and preobese-obese (PreOB/OB) compared to normal weight lean women (NWL). 60 women were enrolled. At baseline and after a 3-week probiotic oral suspension (POS) intake, all subjects underwent evaluation of body composition by anthropometry and dual X-ray absorptiometry, and psychological profile assessment by self-report questionnaires (i.e. EDI-2, SCL90R and BUT). Statistical analysis was carried out using paired t test or a non-parametric Wilcoxon test to evaluate differences between baseline and after POS intake, one-way ANOVA to compare all three groups and, where applicable, Chi square or t test were used to assess symptoms. Of the 48 women that concluded the study, 24% were NWO, 26% were NWL and 50% were PreOB/OB. Significant differences in body composition were highlighted among groups both at baseline and after a POS (p women. At baseline and after POS intake, all subjects tested were negative to SCL90R_GSI scale, but after treatment subjects positive to BUT_GSI scale were significantly reduced (8.33%) (p women. Further research is needed on a larger population and for a longer period of treatment before definitive conclusions can be made. Trial registration ClinicalTrials.gov Id: NCT01890070.

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The Use of Probiotics in Gastrointestinal Disease

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Karen L Madsen

2001-01-01

Full Text Available Probiotics are living microorganisms that can affect the host in a beneficial manner. Prebiotics are nondigestible food ingredients that stimulate the growth and activity of probiotic bacteria already established in the colon. Efficacy of probiotic compounds has been shown in a wide range of gastrointestinal diseases. Lactobacillus GG alone, or the combination of Bifidobacterium bifidum and Streptococcus thermophilus, is effective in the treatment of Clostridium difficile, as well as in preventing the frequency and severity of infectious acute diarrhea in children. Prevention of antibiotic-induced diarrhea with the concomitant administration of either Lactobacillus GG or Saccharomyces boulardii has been demonstrated. The most successful studies involve the use of Lactobacillus GG at a dose of 1×1010 viable organisms per day and the yeast boulardii at a dose of 1 g/day. A probiotic preparation (VSL#3 - 6 g/day that uses a combination of three species of Bifidobacterium, four strains of Lactobacillus and one strain of Streptocccus has shown promise in maintaining remission in ulcerative colitis and pouchitis, as well as in preventing the postoperative recurrence of Crohn's disease. The mechanism of action of probiotics may include receptor competition, effects on mucin secretion or probiotic immunomodulation of gut-associated lymphoid tissue. Oral administration of probiotic compounds has been demonstrated to be well tolerated and safe. However, while probiotics have the potential to improve human health and to prevent and treat some diseases, major improvements are needed in labelling and quality assurance procedures for probiotic compounds. In addition, well planned and controlled clinical studies are necessary to delineate fully the potential for probiotic compounds.

CLINICAL AND PHARMACOECONOMIC REASONABILITY OF USING PROBIOTIC ENTEROCOCCUS STRAIN FOR THE COMPLEX DEVELOPMENTAL CARE PROGRAM FOR PREMATURE INFANTS

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N. V. Gonchar

2015-01-01

Full Text Available Introduction. Possibilities of using probiotic enterococci in premature neonates undergoing inpatient antibacterial therapy remains understudied. The article is aimed at analyzing clinical and pharmacoeconomic reasonability of using probiotic Enterococcus faecium L3 strain in premature infants with very low body weight in the framework of complex inpatient developmental care. Patients and methods. 55 children randomized into 2 groups were observed: the control group (n = 26 was undergoing standard developmental care program, the primary group (n = 29 was introduced liquid probiotic Enterococcus faecium L3 strain (titer — 108 CFU/ml or more (0.5 ml TID for 14 days after attaining the enteral feeding volume of 5.0 ml. Results. Analysis of the clinical symptoms characteristic of non-smooth course of developmental care over premature infants helped to reveal higher frequency of infectious complications in the control group children than in the primary group (14 [53.8%] vs. 6 [20.7%]; p < 0.05. Acute food intolerance was observed less frequently in the primary group than in the control group (6 [20.7%] vs. 10 [38.5%], p > 0.05. The primary group's children featured significant decrease in the frequency of monocytosis, positive changes of intestinal microbiotic composition (increase in the amount of bifidum bacteria, lactobacilli, enterococci, decrease in the amount of Clostridium difficile and antibiotic-resistant clinical Klebsiella pneumoniae strains. Conclusion. Favorable outcome of developmental care over premature infants (absence of infectious complications was less expensive in the primary group's children.

Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial.

Science.gov (United States)

Villar-García, Judit; Güerri-Fernández, Robert; Moya, Andrés; González, Alicia; Hernández, Juan J; Lerma, Elisabet; Guelar, Ana; Sorli, Luisa; Horcajada, Juan P; Artacho, Alejandro; D Auria, Giuseppe; Knobel, Hernando

2017-01-01

Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP) and systemic inflammation (IL-6) in 44 HIV virologically suppressed patients, half of whom (n = 22) had immunologic non-response to antiretroviral therapy (Saccharomyces boulardii is due to modified gut microbiome composition, with a decrease of some species associated with higher systemic levels of microbial translocation and inflammation. In this study, we used 16S rDNA gene amplification and parallel sequencing to analyze the probiotic impact on the composition of the gut microbiome (faecal samples) in these 44 patients randomized to receive oral supplementation with probiotic or placebo for 12 weeks. Compared to the placebo group, in individuals treated with probiotic we observed lower concentrations of some gut species, such as those of the Clostridiaceae family, which were correlated with systemic levels of bacterial translocation and inflammation markers. In a sub-study of these patients, we observed significantly higher parameters of microbial translocation (LBP, soluble CD14) and systemic inflammation in immunologic non-responders than in immunologic responders, which was correlated with a relative abundance of specific gut bacterial groups (Lachnospiraceae genus and Proteobacteria). Thus, in this work, we propose a new therapeutic strategy using the probiotic yeast S. boulardii to modify gut microbiome composition. Identifying pro-inflammatory species in the gut microbiome

The Clinical and Economic Impact of Probiotics Consumption on Respiratory Tract Infections: Projections for Canada.

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Irene Lenoir-Wijnkoop

Full Text Available There is accumulating evidence supporting the use of probiotics, which are defined as "live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host", as a preventive measure against respiratory tract infections (RTI. Two recent meta-analyses showed probiotic consumption (daily intake of 107 to 1010 CFU in any form for up to 3 months significantly reduced RTI duration, frequency, antibiotic use and work absenteeism.The aim of this study was to assess the impact of probiotic use in terms of number of RTI episodes and days averted, and the number of antibiotic prescriptions and missed workdays averted, in the general population of Canada. In addition, the corresponding economic impact from both a healthcare payer and a productivity perspective was estimated.A microsimulation model was developed to reproduce the Canadian population (sample rate of 1/1000 = 35 540 individuals employing age and gender. RTI incidence was taken from FluWatch consultation rates for influenza-like illness (2013-14 and StatCan all-cause consultations statistics. The model was calibrated on a 2.1% RTI annual incidence in the general population (5.2 million RTI days and included known risk factors (smoking status, shared living conditions and vaccination status. RTI-related antibiotic prescriptions and work absenteeism were obtained from the literature.The results indicate that probiotic use saved 573 000-2.3 million RTI-days, according to the YHEC-Cochrane scenarios respectively. These reductions were associated with an avoidance of 52 000-84 000 antibiotic courses and 330 000-500 000 sick-leave days. A projection of corresponding costs reductions amounted to Can$1.3-8.9 million from the healthcare payer perspective and Can$61.2-99.7 million when adding productivity losses.The analysis shows that the potential of probiotics to reduce RTI-related events may have a substantial clinical and economic impact in Canada.

The Clinical and Economic Impact of Probiotics Consumption on Respiratory Tract Infections: Projections for Canada

Science.gov (United States)

Gerlier, Laetitia; Roy, Denis; Reid, Gregor

2016-01-01

Introduction There is accumulating evidence supporting the use of probiotics, which are defined as “live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host”, as a preventive measure against respiratory tract infections (RTI). Two recent meta-analyses showed probiotic consumption (daily intake of 107 to 1010 CFU in any form for up to 3 months) significantly reduced RTI duration, frequency, antibiotic use and work absenteeism. Objectives The aim of this study was to assess the impact of probiotic use in terms of number of RTI episodes and days averted, and the number of antibiotic prescriptions and missed workdays averted, in the general population of Canada. In addition, the corresponding economic impact from both a healthcare payer and a productivity perspective was estimated. Methods A microsimulation model was developed to reproduce the Canadian population (sample rate of 1/1000 = 35 540 individuals) employing age and gender. RTI incidence was taken from FluWatch consultation rates for influenza-like illness (2013–14) and StatCan all-cause consultations statistics. The model was calibrated on a 2.1% RTI annual incidence in the general population (5.2 million RTI days) and included known risk factors (smoking status, shared living conditions and vaccination status). RTI-related antibiotic prescriptions and work absenteeism were obtained from the literature. Results The results indicate that probiotic use saved 573 000–2.3 million RTI-days, according to the YHEC–Cochrane scenarios respectively. These reductions were associated with an avoidance of 52 000–84 000 antibiotic courses and 330 000–500 000 sick-leave days. A projection of corresponding costs reductions amounted to Can$1.3–8.9 million from the healthcare payer perspective and Can$61.2–99.7 million when adding productivity losses. Conclusion The analysis shows that the potential of probiotics to reduce RTI-related events may have a substantial

Effect of Probiotic Yogurt and Xylitol-Containing Chewing Gums on Salivary S Mutans Count.

Science.gov (United States)

Ghasemi, Elnaz; Mazaheri, Romina; Tahmourespour, Arezoo

In addition to improving gastrointestinal health and intestinal microflora, probiotic bacteria have been recently suggested to decrease cariogenic agents in the oral cavity. The aim of this study was to investigate the effects of probiotic yogurt and xylitol-containing chewing gums on reducing salivary Streptococcus mutans levels. This randomized clinical trial recruited 50 female students with over 10 5 colony forming units S. mutans per milliliter of their saliva. The participants were randomly allocated to two equal groups to receive either probiotic yogurt containing Lactobacillus acidophilus ATCC 4356 andBifidobacteriumbifidum ATCC 29521 (200 g daily) or xylitol-containing chewing gums (two gums three times daily after each meal; total xylitol content: 5.58 g daily) for three weeks. At baseline and one day, two weeks, and four weeks after the interventions, saliva samples were cultured on mitis-salivarius-bacitracin agar and salivary S. mutans counts were determined. Data were analyzed with independent t-tests, analysis of variance, and Fisher's least significant difference test. In both groups, S. mutans counts on the first day, second week, and fourth weeks after the intervention were significantly lower than baseline values (P yogurt consumers, the difference between the two groups was not statistically significant. Probiotic yogurt and xylitol-containing chewing gums seem to be as effective in reduction of salivary S. mutans levels. Their constant long-term consumption is thus recommended to prevent caries.

Clinical Trials

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Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

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Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

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Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

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Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

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Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

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Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

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Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

The effects of probiotics in lactose intolerance: A systematic review.

Science.gov (United States)

Oak, Sophia J; Jha, Rajesh

2018-02-09

Over 60 percent of the human population has a reduced ability to digest lactose due to low levels of lactase enzyme activity. Probiotics are live bacteria or yeast that supplements the gastrointestinal flora. Studies have shown that probiotics exhibit various health beneficial properties such as improvement of intestinal health, enhancement of the immune responses, and reduction of serum cholesterol. Accumulating evidence has shown that probiotic bacteria in fermented and unfermented milk products can be used to alleviate the clinical symptoms of lactose intolerance (LI). In this systematic review, the effectiveness of probiotics in the treatment of LI was evaluated using 15 randomized double-blind studies. Eight probiotic strains with the greatest number of proven benefits were studied. Results showed varying degrees of efficacy but an overall positive relationship between probiotics and lactose intolerance.

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

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Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

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Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

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Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

Social media in clinical trials.

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Thompson, Michael A

2014-01-01

Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

Clinical Trials

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Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

Science.gov (United States)

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

Probiotics in Curing Allergic and Inflammatory Conditions - Research Progress and Futuristic Vision.

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Dhama, Kuldeep; Latheef, Shyma K; Munjal, Ashok K; Khandia, Rekha; Samad, Hari A; Iqbal, Hafiz M N; Joshi, Sunil K

2017-01-01

, infantile diarrhoea due to infections, bacterial vaginosis, urinary tract infections, dental carries, diabetes, cancers as well augmenting the gut mucosal tolerance to various antibiotics and lactose intolerance. The resent review gives an insight towards potent utility of this branch of beneficial microbial therapy in allergy and inflammations, which is still in the emerging phase and more scientific evidences need to be explored regarding exploration of the mechanisms of action, further experimental trials and validation of controlled clinical studies in humans along with designing novel strategies for monitoring the possible microbial changes in their composition and metabolism associated with their interaction upon host immune system. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The effect of probiotics as a treatment for constipation in elderly people: A systematic review.

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Martínez-Martínez, Maria Isabel; Calabuig-Tolsá, Raquel; Cauli, Omar

2017-07-01

Treating constipation in elderly people remains a challenge; the administration of probiotics may be a valid therapy for this problem as an alternative to traditional drug-based treatments. The objective of this systematic review was to evaluate the efficiency of probiotics in treating constipation in elderly people. Articles related to this topic and published, without any time limitations, in the Medline, Embase, Scopus, Lilacs, or Cochrane databases were systematically reviewed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The primary search terms were 'constipation' and 'probiotics'. The main inclusion criteria were: 1) the article was original and the whole text was published in English or Spanish and 2) included the primary search terms in the title, summary, or body text; 3) the studies had to have included 60 or more participants defined as 'elderly' and 4) have specifically evaluated the effect of the administration of probiotics. Of the 475 articles consulted, 9 met the inclusion criteria. Among the selected studies, there were four randomised and placebo-controlled trials and the remaining five reports were observational. Overall, our analysis of the randomised and placebo-controlled trials suggests that administration of probiotics significantly improved constipation in elderly individuals by 10-40% compared to placebo controls in which no probiotic was administered. The strain of bacteria most commonly tested was Bifidobacterium longum. However, caution is needed when interpreting these reports because of the heterogeneity of the original study designs, populations, and the risk of bias. Therefore, further placebo-controlled trials are necessary to determine the most efficient strains, doses, and the optimal treatment duration. Copyright © 2017 Elsevier B.V. All rights reserved.

Are probiotics a feasible intervention for prevention of diarrhoea in the developing world?

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Hajela Neerja

2010-08-01

Full Text Available Abstract With more than 1.4 million of the 9 million child deaths being attributed to diarrhoea in 2008 and 49% of them occurring in five countries namely, India, Nigeria, Democratic Republic of the Congo, Pakistan and China, there is an urgent need for intervention to prevent and control diarrhoeal diseases. Of the various interventions, probiotics offer immense potential. The past decade has witnessed the validation of their utility for the prevention, treatment and management of a variety of infective and non infective disorders. The most investigated field continues to remain infectious diarrhoea and compelling evidence comes from randomized placebo controlled trials. While results from these studies are encouraging most of them reflect the outcomes of the developed world. Developing countries like India continue to struggle with nutritional and health challenges and bear the greatest burden of diarrhoea. A paucity of data from the developing countries limits the definite recommendation of probiotics. In these countries curd, often confused for a probiotic, is practiced as an integral part of the culture. While the nutritional benefits of these products cannot be understated, it is still uncertain whether these products can be classified as a probiotic. The emergence of probiotic foods which are scientifically validated for their efficacy and impart defined health benefits offer an excellent opportunity to improve public health. A recent randomized controlled trial conducted by the National Institute of Cholera and Enteric Diseases in Kolkata, India demonstrated a protective efficacy of 14% in preventing diarrhoea among children who received a probiotic. For the developing world however the vision for probiotics would mean a fundamental change in perception and developing a well planned strategy to allow interventions like probiotics to permeate to impoverished settings, where the assault of micro organisms is on a daily basis. This would

Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

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Stapleton, Ann E; Au-Yeung, Melissa; Hooton, Thomas M; Fredricks, David N; Roberts, Pacita L; Czaja, Christopher A; Yarova-Yarovaya, Yuliya; Fiedler, Tina; Cox, Marsha; Stamm, Walter E

2011-05-01

Urinary tract infections (UTIs) are common among women and frequently recur. Depletion of vaginal lactobacilli is associated with UTI risk, which suggests that repletion may be beneficial. We conducted a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic (Lactin-V; Osel) for prevention of recurrent UTI in premenopausal women. One hundred young women with a history of recurrent UTI received antimicrobials for acute UTI and then were randomized to receive either Lactin-V or placebo daily for 5 d, then once weekly for 10 weeks. Participants were followed up at 1 week and 10 weeks after intervention and for UTIs; urine samples for culture and vaginal swabs for real-time quantitative 16S ribosomal RNA gene polymerase chain reaction for L. crispatus were collected. Recurrent UTI occurred in 7/48 15% of women receiving Lactin-V compared with 13/48 27% of women receiving placebo (relative risk [RR], .5; 95% confidence interval, .2-1.2). High-level vaginal colonization with L. crispatus (≥10(6) 16S RNA gene copies per swab) throughout follow-up was associated with a significant reduction in recurrent UTI only for Lactin-V (RR for Lactin-V, .07; RR for placebo, 1.1; P < .01). Lactin-V after treatment for cystitis is associated with a reduction in recurrent UTI. Larger efficacy trials of this novel preventive method for recurrent UTI are warranted. CLINICAL TRIALS REGISTRATION. NCT00305227.

Formulation and Design of Probiotic Supplements for Rheumatoid Arthritis Patients

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Elnaz Vaghef-Mehrabani

2018-03-01

Full Text Available Background: Probiotics are live microorganisms with immune-regulatory properties and may be useful for patients suffering from rheumatoid arthritis (RA, an autoimmune inflammatory disorder. The aim of the present study was to formulate L. casei 01 capsules at laboratory scale, and evaluate its effects on the proportion of T-helper type 2 (Th2 anti-inflammatory cytokines to T-helper type 1 (Th1 pro-inflammatory cytokines (Th2/Th1, in RA patients. Methods: After blending the probiotic and excipient (maltodextrin based on the relevant calculations, the content uniformity of the mixture was evaluated. Furthermore, viability of the probiotic bacteria was assessed during capsules production and throughout three months of storage. In a randomized double-blind placebo-controlled trial, 46 RA patients were supplemented with either the capsules (containing at least 108 CFU of Lactobacillus. casei 01 or placebo (maltodextrin, for eight weeks; DAS28 (Disease activity score 28 as well as serum inflammatory cytokines (TNF-α, IL-1β, IL-6, IL-10 and IL-12 were measured at baseline and the end of study. IL-10/IL-1β, IL-10/IL-6, IL-10/IL-12, IL10/TNF-α and IL-10/(IL-1β+ IL-6+ IL-12+ TNF-α were calculated, the latter being expressed as IL-10/total Th1, and compared for the groups. Paired samples t test, Wilcoxon signed-rank test and ANCOVA tests were applied. Results: Probiotic powder had been uniformly mixed with the excipient and the bacteria had acceptable viability throughout the study course. Supplementation of RA patients with the capsules resulted in a significant decrease in disease activity (DAS28, P=0.039 and increase in IL-10/TNF-α, IL-10/IL-12 and IL-10/total Th1 (P=0.039, P=0.012 and P=0.014, respectively. At the end of the study, there was a significant difference between the two groups in terms of IL-10/IL-12 and IL-10/total Th1 (P= 0.038 and P= 0.006, respectively. Conclusion: L. casei 01 supplements may have the expected desired anti

Probiotics, prebiotics infant formula use in preterm or low birth weight infants: a systematic review

Science.gov (United States)

2012-01-01

Background Previous reviews (2005 to 2009) on preterm infants given probiotics or prebiotics with breast milk or mixed feeds focused on prevention of Necrotizing Enterocolitis, sepsis and diarrhea. This review assessed if probiotics, prebiotics led to improved growth and clinical outcomes in formula fed preterm infants. Methods Cochrane methodology was followed using randomized controlled trials (RCTs) which compared preterm formula containing probiotic(s) or prebiotic(s) to conventional preterm formula in preterm infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Heterogeneity was assessed by visual inspection of forest plots and a chi2 test. An I2 test assessed inconsistencies across studies. I2> 50% represented substantial heterogeneity. Results Four probiotics studies (N=212), 4 prebiotics studies (N=126) were included. Probiotics: There were no significant differences in weight gain (MD 1.96, 95% CI: -2.64 to 6.56, 2 studies, n=34) or in maximal enteral feed (MD 35.20, 95% CI: -7.61 to 78.02, 2 studies, n=34), number of stools per day increased significantly in probiotic group (MD 1.60, 95% CI: 1.20 to 2.00, 1 study, n=20). Prebiotics: Galacto-oligosaccharide / Fructo-oligosaccharide (GOS/FOS) yielded no significant difference in weight gain (MD 0.04, 95% CI: -2.65 to 2.73, 2 studies, n=50), GOS/FOS yielded no significant differences in length gain (MD 0.01, 95% CI: -0.03 to 0.04, 2 studies, n=50). There were no significant differences in head growth (MD −0.01, 95% CI: -0.02 to 0.00, 2 studies, n=76) or age at full enteral feed (MD −0.79, 95% CI: -2.20 to 0.61, 2 studies, n=86). Stool frequency increased significantly in prebiotic group (MD 0.80, 95% CI: 0.48 to 1.1, 2 studies, n=86). GOS/FOS and FOS yielded higher bifidobacteria counts in prebiotics group (MD 2.10, 95% CI: 0.96 to 3.24, n=27) and (MD 0.48, 95% CI: 0

Clinical trials in dentistry in India: Analysis from trial registry.

Science.gov (United States)

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

Comparison between oral antibiotics and probiotics as bowel preparation for elective colon cancer surgery to prevent infection: prospective randomized trial.

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Sadahiro, Sotaro; Suzuki, Toshiyuki; Tanaka, Akira; Okada, Kazutake; Kamata, Hiroko; Ozaki, Toru; Koga, Yasuhiro

2014-03-01

We have already reported that, for patients undergoing elective colon cancer operations, perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented. Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations. The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial. Three hundred ten patients with colon cancer randomly were assigned to one of three groups. All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation. Probiotics were administered in Group A; oral antibiotics were administered in Group B; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure. Clostridium difficile toxin and the number of bacteria in the intestine were determined. The rates of incisional surgical-site infection were 18.0%, 6.1%, and 17.9% in Groups A, B, and C, and the rates of leakage were 12.0%, 1.0%, and 7.4% in Groups A, B, and C, respectively, indicating that both rates were lesser in Group B than in Groups A and C (P = .014 and P = .004, respectively). The detection rates of C. difficile toxin were not changed among the three groups. We recommend oral antibiotics, rather than probiotics, as bowel preparation for elective colon cancer procedures to prevent surgical-site infections. Copyright © 2014 Mosby, Inc. All rights reserved.

Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

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Vojtech Huser

Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

Clinical Trials

Medline Plus

Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study.

Science.gov (United States)

Ringel-Kulka, Tamar; Palsson, Olafur S; Maier, Danielle; Carroll, Ian; Galanko, Joseph A; Leyer, Gregory; Ringel, Yehuda

2011-07-01

Recent data suggest a role for the intestinal microbiota in the pathogenesis of functional bowel disorders (FBDs). Probiotic studies in FBDs generated inconsistent results suggesting a strain-specific and product-specific effect. To investigate the clinical efficacy of Lactobacillus acidophilus NCFM (L-NCFM) and Bifidobacterium lactis Bi-07 (B-LBi07) in nonconstipation FBDs. A double-blind, placebo-control clinical trial of the probiotic bacterias L-NCFM and B-LBi07 twice a day (2×10(11) CFU/d) versus placebo over 8 weeks. Primary endpoints were global relief of gastrointestinal symptoms and satisfaction with treatment. Secondary endpoints were change in symptoms severity, well-being, and quality of life. Microbiological effect was assessed by quantitative real time polymerase chain reaction on fecal samples. Sixty patients (probiotic, n=31; placebo, n=29), 72% females, 84% whites, mean age 37 years. Abdominal bloating improved in the probiotics compared with the placebo group at 4 weeks (4.10 vs 6.17, P=0.009; change in bloating severity P=0.02) and 8 weeks (4.26 vs 5.84, P=0.06; change in bloating severity Pbacteria in the pathophysiology of FBD and the role for probiotic bacteria in the management of these disorders.

Gut microbiota and probiotics intervention: A potential therapeutic target for management of cardiometabolic disorders and chronic kidney disease?

Science.gov (United States)

Cavalcanti Neto, Marinaldo Pacífico; Aquino, Jailane de Souza; Romão da Silva, Larissa de Fátima; de Oliveira Silva, Ruanniere; Guimarães, Keyth Sulamitta de Lima; de Oliveira, Yohanna; de Souza, Evandro Leite; Magnani, Marciane; Vidal, Hubert; de Brito Alves, José Luiz

2018-04-01

The gut microbiota plays an important role in host metabolism and its dysregulation have been related to cardiometabolic disorders (CMD), such as type 2 diabetes mellitus (T2D), dyslipidemia and arterial hypertension, as well as to chronic kidney diseases (CKD). The implication of the gut microbiota on systemic disorders has been associated with changes in its composition (dysbiosis) as a result of the oxidative unbalance in the body. This alteration may be the result of the adoption of unhealthy lifestyle behavior, including lack of physical activity and fat- or sugar-rich diets, which are largely associated with increased incidence of CMD and CKD. In last years, a number of clinical trials and experimental studies have demonstrated that probiotics can modulate the host metabolism, resulting in amelioration of systemic disease phenotypes by the improvement of dyslipidemia, glycemic profile and blood pressure or CKD parameters. The beneficial effects of probiotics consumption have been associated with their anti-inflammatory, antioxidant and gut-modulating properties. Despite of some mechanistic evidence, these effects are not totally elucidated. The present review summarizes and clarifies the effects of probiotics administration on CMD and CKD using combined evidence from clinical and experimental studies. Considering that the microbiota dysregulation has been associated with inflammation and oxidative stress and consequently with CMD and CKD, supplementation with probiotics is discussed as a strategy for management of CMD and CKD. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of competitive exclusion in rabbits using an autochthonous probiotic

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Sara Cunha

2017-06-01

Full Text Available Animal nutrition has been severely challenged by the ban on antimicrobials as growth promoters. This has fostered the study of alternative methods to avoid colonisation by pathogenic bacteria as well as to improve the growth of animals and feed conversion efficiency. These new options should not alter the normal intestinal microbiota, or affect it as little as possible. The use of probiotics, which are live microorganisms that beneficially affect the host by improving its intestinal microbial balance, can be seen as a promising way to achieve that goal. In this study, New Zealand White rabbits were fed diets containing an autochthonous probiotic of Enterococcus spp., with the strains EaI, EfaI and EfaD, and Escherichia coli, with the strains ECI 1, ECI 2 and ECD, during a 25-d trial, to evaluate the impact of the probiotic on the faecal microbiota, including population dynamics and antimicrobial resistance profiles. A control group of rabbits, which was fed a diet containing a commonly used mixture of antimicrobials (colistin, oxytetracycline, and valnemulin, was also studied. To assess the colonisation ability of the mentioned probiotic, the faecal microbiota of the rabbits was characterised up to 10 d after the administration had ended. Isolates of enterococci and E. coli were studied for phylogenetic relationships using enterobacterial repetitive intergenic consensus (ERIC-PCR and pulse-field gel electrophoresis (PFGE, respectively. Although partially affected by an unexpected clinical impairment suffered by the rabbits in the experimental group, our results showed the following. The difference between the growth rate of the animals treated with antimicrobials and those fed the probiotic was not statistically significant (P> 0.05. The competitive exclusion product was present in the faecal samples in a large proportion, but stopped being recovered by culture as soon as the administration ended and the housing conditions were changed

Development of Probiotic Formulation for the Treatment of Iron Deficiency Anemia.

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Korčok, Davor Jovan; Tršić-Milanović, Nada Aleksandar; Ivanović, Nevena Djuro; Đorđević, Brižita Ivan

2018-04-01

Probiotics are increasingly more present both as functional foods, and in pharmaceutical preparations with multiple levels of action that contribute to human health. Probiotics realize their positive effects with a proper dose, and by maintaining a declared number of probiotics cells by the expiration date. Important precondition for developing a probiotic product is the right choice of clinically proven probiotic strain, the choice of other active components, as well as, the optimization of the quantity of active component of probiotic per product dose. This scientific paper describes the optimization of the number of probiotics cells in the formulation of dietary supplement that contains probiotic culture Lactobacillus plantarum 299v, iron and vitamin C. Variations of the quantity of active component were analyzed in development batches of the encapsulated probiotic product categorized as dietary supplement with the following ingredients: probiotic culture, sucrosomal form of iron and vitamin C. Optimal quantity of active component L. plantarum of 50 mg, was selected. The purpose of this scientific paper is to select the optimal formulation of probiotic culture in a dietary supplement that contains iron and vitamin C, and to also determine its expiration date by the analysis of the number of viable probiotic cells.

The effects of probiotics supplementation on metabolic health in pregnant women: An evidence based meta-analysis.

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Jia Zheng

Full Text Available The prevalence of maternal obesity and gestational diabetes mellitus (GDM is increasing rapidly. Probiotics supplementation have been shown to improve metabolic health in humans. In our study, we aimed to evaluate the effects of probiotics supplementation on metabolic health and pregnancy complications in pregnant women. The literature search, data extraction and quality assessment were performed, and data were synthesized in accordance with standardized guidelines. Ten randomized clinical trials with eligible data were included in our meta-analysis. For pregnant women with GDM, we found negative correlations between probiotics supplementation and fasting serum insulin (OR -2.94, 95%CI [-5.69, -0.20], p = 0.04 and homoeostasis model assessment for insulin resistance (HOMA-IR (OR -0.65, 95%CI [-1.18, -0.11], p = 0.02. There were no significant correlations between probiotics supplementation and lipid levels in women with GDM, including total cholesterol (OR -2.72, 95%CI [-17.18, 11.74], P = 0.71, high density lipoprotein cholesterol (HDL-c (OR -0.29, 95%CI [-3.60, 3.03], P = 0.87, low density lipoprotein cholesterol (LDL-c (OR -0.38, 95%CI [-18.54, 17.79], P = 0.97, or triglycerides (OR -12.83, 95%CI [-36.63, 10.97], P = 0.29. For healthy pregnant women, probiotics supplementation were negatively associated with fasting serum insulin (OR -3.76, 95%CI [-4.29, -3.23], P < 0.00001 and HOMA-IR (OR -0.57, 95%CI [-1.08, -0.06], p = 0.03. However, no significant correlations were observed between probiotics supplementation and fasting plasma glucose (FPG (OR -2.02, 95%CI [-5.56, 1.52], p = 0.26. Thus, our study revealed that probiotics supplementation during pregnancy have beneficial effects on glucose metabolism, rather than lipid metabolism among pregnant women.

New perspectives on probiotics in health and disease

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Eric Banan-Mwine Daliri

2015-06-01

Full Text Available The gut microbiota continues to fascinate scientists in many realms when it is considered that humans contain 90% bacteria. Correlations between changes in composition and activity of the gut microbiota and common disorders such as cancer, hypertension, hypercholesterolemia, inflammatory bowel diseases, obesity, oral health, etc. have been proposed. What is the real role of probiotics, prebiotics and synbiotics in influencing a healthy microbiota? Both in vitro evidences and in vivo clinical data have supported some of these new health claims, while recent molecular advancement has provided strong indications to support and justify the hypotheses. However, probiotics validity and health claims have continuously been rejected on the basis of “biomarker deficiency”. To battle the increase in health care costs, a preventive approach to medicine with the development of probiotics and prebiotics or symbiotic products is being advanced. This review discusses the potential beneficial effects of probiotics in preventing and treating certain diseases as well as current and future perspectives of probiotic research.

Probiotics, D–Lactic acidosis, oxidative stress and strain specificity

Science.gov (United States)

2017-01-01

ABSTRACT The existence of an implicit living microscopic world, composed primarily of bacteria, has been known for centuries. The exact mechanisms that govern the contribution of bacteria to human health and disease have only recently become the subject of intense research efforts. Within this very evident shift in paradigms, the rational design of probiotic formulations has led to the creation of an industry that seeks to progress the engineering of probiotic bacteria that produce metabolites that may enhance human host health and prevent disease. The promotion of probiotics is often made in the absence of quality scientific and clinically plausible data. The latest incursions into the probiotic market of claims have posited the amelioration of oxidative stress via potent antioxidant attributes or limiting the administration of probiotics to those species that do not produce D-Lactic acid (i.e., claims that D-Lactic acid acidosis is linked to chronic health conditions) or are strain-specific (shaping an industry point of difference) for appraising a therapeutic effect. Evidence-based research should guide clinical practice, as there is no place in science and medicine that supports unsubstantiated claims. Extravagant industry based notions continue to fuel the imprimatur of distrust and skepticism that is leveled by scientists and clinicians at an industry that is already rife with scientific and medical distrust and questionable views on probiotics. Ignoring scientifically discordant data, when sorting through research innovations and false leads relevant to the actions of probiotics, drives researcher discomfit and keeps the bar low, impeding the progress of knowledge. Biologically plausible posits are obligatory in any research effort; companies formulating probiotics often exhibit a lack of analytical understanding that then fuels questionable investigations failing to build on research capacity. PMID:28080206

Probiotics, D-Lactic acidosis, oxidative stress and strain specificity.

Science.gov (United States)

Vitetta, Luis; Coulson, Samantha; Thomsen, Michael; Nguyen, Tony; Hall, Sean

2017-07-04

The existence of an implicit living microscopic world, composed primarily of bacteria, has been known for centuries. The exact mechanisms that govern the contribution of bacteria to human health and disease have only recently become the subject of intense research efforts. Within this very evident shift in paradigms, the rational design of probiotic formulations has led to the creation of an industry that seeks to progress the engineering of probiotic bacteria that produce metabolites that may enhance human host health and prevent disease. The promotion of probiotics is often made in the absence of quality scientific and clinically plausible data. The latest incursions into the probiotic market of claims have posited the amelioration of oxidative stress via potent antioxidant attributes or limiting the administration of probiotics to those species that do not produce D-Lactic acid (i.e., claims that D-Lactic acid acidosis is linked to chronic health conditions) or are strain-specific (shaping an industry point of difference) for appraising a therapeutic effect. Evidence-based research should guide clinical practice, as there is no place in science and medicine that supports unsubstantiated claims. Extravagant industry based notions continue to fuel the imprimatur of distrust and skepticism that is leveled by scientists and clinicians at an industry that is already rife with scientific and medical distrust and questionable views on probiotics. Ignoring scientifically discordant data, when sorting through research innovations and false leads relevant to the actions of probiotics, drives researcher discomfit and keeps the bar low, impeding the progress of knowledge. Biologically plausible posits are obligatory in any research effort; companies formulating probiotics often exhibit a lack of analytical understanding that then fuels questionable investigations failing to build on research capacity.

Effect of probiotic Lactobacillus strains in children with atopic dermatitis

DEFF Research Database (Denmark)

Rosenfeldt, Vibeke; Benfeldt, Eva; Nielsen, Susanne Dam

2003-01-01

BACKGROUND: Recent studies suggest that oral bacteriotherapy with probiotics might be useful in the management of atopic dermatitis (AD). OBJECTIVE: The purpose of this investigation was to evaluate the clinical and anti-inflammatory effect of probiotic supplementation in children with AD. METHOD...

The Microbiome of Infants Recruited to a Randomised Placebo-controlled Probiotic Trial (PiPS Trial

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Michael Millar

2017-06-01

These findings highlight that the potential influence of probiotics on the microbiome of preterm infants remains unclear whereas the modulatory effect of antibiotic exposure on microbial colonisation requires further research.

Association between probiotic and yogurt consumption and kidney disease: insights from NHANES.

Science.gov (United States)

Yacoub, Rabi; Kaji, Deepak; Patel, Shanti N; Simoes, Priya K; Busayavalasa, Deepthi; Nadkarni, Girish N; He, John C; Coca, Steven G; Uribarri, Jaime

2016-01-27

Data from experimental animals suggest that probiotic supplements may retard CKD progression. However, the relationship between probiotic use, frequent yogurt consumption (as a natural probiotic source), and kidney parameters have not been evaluated in humans. We utilized NHANES data, and analyzed the association of probiotic alone (1999-2012) and yogurt/probiotic (2003-2006) use with albuminuria and eGFR after adjustment for demographic and clinical parameters. Frequent yogurt consumption was defined as thrice or more weekly over the year prior to the interview. Frequent yogurt/probiotic consumers had lower adjusted odds of developing combined outcome (albuminuria and/or eGFR yogurt and/or probiotics use is associated with decreased odds of proteinuric kidney disease. These hypothesis-generating results warrant further translational studies to further delineate the relationship between yogurt/probiotics with kidney dysfunction, as well as microbiome and dysbiosis as potential mediators.

Construction of ethics in clinical research: clinical trials registration

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C. A. Caramori

2007-01-01

Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Research Areas - Clinical Trials

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Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

Probiotics for the treatment of Clostridium difficile associated disease

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Fitzpatrick, Leo R

2013-01-01

The purpose of this review paper is to update the current and potential future role of probiotics for Clostridium difficile-associated disease (CDAD). Included in this review, is an update on the testing of newer probiotics (e.g., Bacillus coagulans GBI-30, 6086) in animal models of CDAD. There is a focus on the modulation of signal transduction pathways (i.e., transcription factors like cAMP response element-binding, activator protein 1, and nuclear factor kappa B), as well as the inhibition of certain kinases (e.g., p38 mitogen activated protein kinases) by probiotics. Inhibition of signal transduction by probiotics, such as Saccharomyces boulardii, result in multiple effects on intestinal fluid secretion, neutrophil influx into the colon, inflammation, and colonocyte apoptosis that may positively impact CDAD. Recent clinical approaches with probiotics, for the prevention of primary and recurrent CDAD, are also summarized in this review paper. Future directions for the treatment of CDAD by probiotics are also mentioned in this review. In particular, the use of multi-strain probiotic formulations such as Ecologic® AAD and VSL #3® may represent a rationale pharmacological approach, particularly as adjunctive therapies for CDAD. Understanding the mechanistic basis of CDAD, and how probiotics interfere at ceratin steps in the pathogenic process, may also present the opportunity to design other multi-strain probiotics that could have a future impact on CDAD. PMID:23946887

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

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Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

2015-05-01

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

[Clinical trials in nursing journals].

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Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

2014-01-01

Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

Science.gov (United States)

Abbas, Ismail; Rovira, Joan; Casanovas, Josep

2007-05-01

The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

Quantification of FITC-labelled probiotic Lactobacillus salivarius DSPV 001P during gastrointestinal transit in broilers.

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Blajman, J E; Astesana, D M; Zimmermann, J A; Rossler, E; Scharpen, A Romero; Berisvil, A P; Zbrun, M V; Soto, L P; Rosmini, M R; Frizzo, L S

2017-02-07

The knowledge related to the fate of probiotics in the complex environment of the intestinal microbiota in broilers is just beginning to be elucidated; however, it is not yet well understood. A good method to investigate the mechanisms by which probiotics mediate their effects is to mark probiotic bacteria and trace them. The aim of this research was to develop a new method to estimate in vivo fluorescein isothiocyanate (FITC)-labelled Lactobacillus salivarius DSPV 001P counts during passage through the gastrointestinal tract (GIT) of broilers. Forty-five, 1 d old Cobb broilers were used in this trial. Programmed necropsies were performed 30 min, 6 h, and 12 h after the administration of the probiotic bacterium, and samples of liver, crop, duodenum, caecum, and bursa of fabricius were collected. To determine the spatial and temporal transit of L. salivarius DSPV 001P in broilers, the number of bacteria as well as its respective fluorescent signal produced by FITC were measured. In order to observe the relationship between the variables, a logistic regression analysis was applied. The amount of fluorescence could be used as an indicator of fluorescent probiotic bacteria in the crop and duodenum 30 min after probiotic bacterium supplementation. In addition, the fluorescent signal could be used to estimate bacterial counts in caecum 6 and 12 h after L. salivarius DSPV 001P administration. To the best of our knowledge, this research is the first in vivo trial to employ the bacterial FITC-labelling technique in order to enumerate probiotic bacteria during gastrointestinal transit in broilers.

Effects of Probiotics on Human Obesity Control: An Unproven Hypothesis

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Amparo Arias

2014-01-01

Full Text Available The objective of the present study is to review the different publications associated with probiotics and obesity, as well as to get some new insights regarding the role of the microbiome in diseases such as obesity. An extensive search for scientific publications (studies in animal models, cells, clinical trials and reviews was performed in the following specialist computer databases (PubMed central (PMC-NCBI, Elsevier Journal, Scielo Spain, Scirus, Science Direct to establish the current status of the potential effect of probiotics in the control of obesity in humans, as well as the relationship between intestinal microbiota and obesity. The intestinal microbiota and oral probiotics have a positive effect on human health, as they can regulate the immune functions and protect from infections and chronic inflammatory processes. Although divergent results have recently been reported, it has been shown but not confirmed that intestinal microbiota might play a role as a new factor associated with the regulation of body weight and obesity-related diseases. The international MetaHIT project has shown that human microbiome populations can be grouped into three different enterotypes. Two of these enterotypes (Bacteroides and Ruminococcus seem to encode functions related to obesity. Although the relationship between intestinal microbiota and obesity are not yet well established, the attempt to manipulate intestinal microbiota through diet is suggested as a new plausible approach to prevent, or modify the risk of, obesity and its related diseases.

USE OF PROBIOTIC BACTERIA IN THE PRODUCTION OF CHEESE : PROBIOTIC CHEESE

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Oğuz GÜRSOY

2006-01-01

Full Text Available The interactions of the gastrointestinal microflora with human health have been the subject of considerable debate in recent years. Disruption of the ecologic equilibrium of the normal intestinal flora may result in gastrointestinal diseases. Functional foods, which are used in prevention and treatment of some intestinal diseases, are defined as "foods that may provide health benefits beyond basic nutrition". Probiotics are constituted an important part of functional foods. Probiotics are live microbial food supplements that beneficially affect the host by improving its intestinal microbial balance. To date, the most popular food delivery systems for probiotic cultures have been fermented milks and yogurts, as well as unfermented milk with cultures added. In an effort to expand the probiotic product range, a small number of researchers and dairy companies have endeavoured to production cheeses, which sustain a high viable count of probiotic cultures. This paper will first outline some of the main aspects about probiotics, cheese microbilogy and probiotic cheese development, and give examples of studies where probiotic microorganisms have been incoorporated into cheese.

The Mexican consensus on probiotics in gastroenterology

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M.A. Valdovinos

2017-04-01

Results and conclusions: Eleven statements on the general concepts of probiotics and 27 statements on the use of probiotics in gastrointestinal diseases in both adults and children were formulated. The consensus group recommends the use of probiotics under the following clinical conditions: the prevention of diarrhea associated with antibiotics, the treatment of acute infectious diarrhea, the prevention of Clostridium difficile infection and necrotizing enterocolitis, the reduction of adverse events from Helicobacter pylori eradication therapy, relief from irritable bowel syndrome symptoms, the treatment of functional constipation in the adult, and the induction and maintenance of remission in patients with ulcerative colitis (UC and pouchitis, and the treatment of covert and overt hepatic encephalopathy.

Probiotics, antibiotics and the immune responses to vaccines.

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Praharaj, Ira; John, Sushil M; Bandyopadhyay, Rini; Kang, Gagandeep

2015-06-19

Orally delivered vaccines have been shown to perform poorly in developing countries. There are marked differences in the structure and the luminal environment of the gut in developing countries resulting in changes in immune and barrier function. Recent studies using newly developed technology and analytic methods have made it increasingly clear that the intestinal microbiota activate a multitude of pathways that control innate and adaptive immunity in the gut. Several hypotheses have been proposed for the underperformance of oral vaccines in developing countries, and modulation of the intestinal microbiota is now being tested in human clinical trials. Supplementation with specific strains of probiotics has been shown to have modulatory effects on intestinal and systemic immune responses in animal models and forms the basis for human studies with vaccines. However, most studies published so far that have evaluated the immune response to vaccines in children and adults have been small and results have varied by age, antigen, type of antibody response and probiotic strain. Use of anthelminthic drugs in children has been shown to possibly increase immunogenicity following oral cholera vaccination, lending further support to the rationale for modulation of the immune response to oral vaccination through the intestinal microbiome. © 2015 The Author(s) Published by the Royal Society. All rights reserved.

Credentialing for participation in clinical trials

International Nuclear Information System (INIS)

Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

2012-01-01

The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

Credentialing for participation in clinical trials

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Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

2012-12-26

The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial.

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Sunil Sazawal

Full Text Available BACKGROUND: Recent reviews suggest common infectious diseases continue to be a major cause of death among preschool children in developing countries. Identification of feasible strategies to combat this disease burden is an important public health need. We evaluated the efficacy of adding prebiotic oligosaccharide and probiotic Bifidobacterium lactis HN019 to milk, in preventing diarrhea, respiratory infections and severe illnesses, in children aged 1-4 years as part of a four group study design, running two studies simultaneously. METHODS AND FINDINGS: In a community based double-masked, randomized controlled trial, children 1-3 years of age, willing to participate, were randomly allocated to receive either control milk (Co; n = 312 or the same milk fortified with 2.4 g/day of prebiotic oligosaccharide and 1.9x10(7 colony forming unit (c.f.u/day of probiotic Bifidobacterium lactis HN019 (PP; n = 312. Children were followed up for 1 year providing data for 1-4 years. Biweekly household surveillance was conducted to gather information on compliance and morbidity. Both study groups were comparable at baseline; compliance to intervention was similar. Overall, there was no effect of prebiotic and probiotic on diarrhea (6% reduction, 95% Confidence Interval [CI]: -1 to 12%; p = 0.08. Incidence of dysentery episodes was reduced by 21% (95% CI: 0 to 38%; p = 0.05. Incidence of pneumonia was reduced by 24% (95% CI: 0 to 42%; p = 0.05 and severe acute lower respiratory infection (ALRI by 35% (95% CI: 0 to 58%; p = 0.05. Compared to children in Co group, children in PP group had 16% (95% CI: 5 to 26%, p = 0.004 and 5% (95% CI: 0 to 10%; p = 0.05 reduction in days with severe illness and high fever respectively. CONCLUSIONS/SIGNIFICANCE: Milk can be a good medium for delivery of prebiotic and probiotic and resulted in significant reduction of dysentery, respiratory morbidity and febrile illness. Overall, impact of diarrhea was not significant. These

Probiotic Properties of Non-Saccharomyces Yeasts

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Smith, Ida Mosbech

to harmless luminal substances is a key feature of the intestinal immune system. In this context, dendritic cells (DCs) present in the tissues lining the human gut are central players involved in microbial sensing and shaping of appropriate adaptive immune responses. Probiotics are live microorganisms which...... when administered in adequate amounts confer a health benefit on the host. While the majority of probiotic microorganisms studied to date are lactic acid bacteria, research in yeasts with potentially beneficial influences on human health has mainly revolved around Saccharomyces boulardii. This yeast...... has shown a positive impact on disease outcome in clinical studies of inflammatory bowel disease, indicating an ability of S. boulardii to influence human immune responses underlying intestinal inflammation. Consequent to this focus on S. boulardii as the fundamental probiotic yeast, very little...

Clinical Trials

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Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

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Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

Clinical Trials