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Sample records for clinical trial probiotic

  1. Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

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    Yadollah Zahed Pasha; Mousa Ahmadpour-kacho; Abes Ahmadi Jazi; Hemmat Gholinia

    2017-01-01

    Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL) is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for photother...

  2. Clinical effects of probiotics containing Bacillus species on gingivitis: a pilot randomized controlled trial.

    Science.gov (United States)

    Alkaya, B; Laleman, I; Keceli, S; Ozcelik, O; Cenk Haytac, M; Teughels, W

    2017-06-01

    Lactobacillus spp. and bifidobacteria are the most frequently used probiotics in oral health research. However, although probiotic effects have been suggested for other genera, such as bacilli, no trials are available to describe the effect of bacilli probiotics on gingivitis in humans. The aim of the present study was to evaluate the clinical effects of a bacilli-containing toothpaste, a mouthrinse and a toothbrush cleaner versus a placebo in patients with generalized gingivitis. In this double-blind placebo-controlled randomized clinical trial, nonsmoking, systemically healthy patients with generalized gingivitis were included. They used a placebo or an experimental probiotic Bacillus subtilis-, Bacillus megaterium- and Bacillus pumulus-containing toothpaste, mouthrinse and toothbrush cleaner for 8 wk. Primary outcome measures of interest were plaque and gingivitis index, and the secondary outcome measures were pocket probing depth and bleeding on probing. Twenty male and 20 female patients were randomized over the two groups. All participants could be included in the final analysis. Although plaque and gingivitis indices were significantly reduced after 8 wk, no intergroup differences could be found at any time point. Also, for the secondary outcome measure, intragroup but no intergroup differences could be detected. No harm or unintended effects were reported by the patients after using the study products. This study did not show any statistically significant differences between a placebo and a bacilli-containing toothpaste, mouthrinse and toothbrush cleaner on gingivitis parameters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

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    Yadollah Zahed Pasha

    2017-10-01

    Full Text Available Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for phototherapy in Amirkola Children’s Hospital, Babol- Iran, during October 5, 2016 till May 19, 2017. Eligible neonates were randomly divided into two; intervention (n=75, and control (n=75 groups. Both groups received standard conventional phototherapy, but the intervention group received 10 drop/day of probiotics (Pedilact Zisttakhmir. Co. Iran, until hospital discharge. The outcome variables were SBL and the duration of phototherapy. The data was analyzed by SPSS 22.0 and   the P 0.05.After 24, 48 and 72hours it decreased to 13.73±1.72, 10.92±1.87 and 10.25±1.32 in the intervention and 13.66±1.91, 11.01±1.69 and10.09 ±1.38 in the control groups, respectively but comparison of the amount of SBL reduction  between the two groups was not significant (P>0.05. The duration of phototherapy in the intervention group and the control group was 3.61±1.17 days and 3.72±1.18 days respectively (P>0.05. Conclusion Oral probiotics in neonates with jaundice has no significant effect on SBL and the duration of phototherapy. Further studies are needed to with longer time follow-up.

  4. Probiotic or Conventional Yogurt for Treating Antibiotic-associated Diarrhea: A Clinical Trial Study

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    Majid Khademian

    2018-03-01

    Full Text Available Background The popularity of probiotics is on the rise. Despite the beneficial effects of antibiotics, gastrointestinal health is at risk of diarrhea. This study aimed to investigate whether probiotic yogurt is of capability to prevent the incidence of diarrhea versus conventional yogurt. Materials and Methods This controlled, randomized, double-blind trial was designed to recruit 48 hospitalized children, whose treatments included different types of antibiotics. They were subsequently assigned into a 1:1 ratio into groups A and B at random. The first group was instructed to consume probiotic yogurt (Bifidobacterium strains and Lactobacillus acidophilus, while the second were on conventional yogurt (placebo containing Streptococcus thermophiles and Lactobacillus bulgaricus at least for 7 days. The incidence of diarrhea, its onset and duration were compared between the two groups. Results The findings indicated that there was no statistically significant difference between the experimental and control groups (p > 0.05. No significant decrease was observed in the incidence of diarrhea between the groups following adjustment for negative C-reactive protein (CRP (p > 0.05. Conclusion According to the results, the consumption of yogurt, either probiotic or conventional, reduced the incidence, duration, and onset of antibiotic-associated diarrhea in pediatric population. This study showed no significantly better performance for probiotic yogurt than conventional yogurt.

  5. Effects of Probiotics and Synbiotics on Obesity, Insulin Resistance Syndrome, Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease: A Review of Human Clinical Trials

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    Maria Jose Sáez-Lara

    2016-06-01

    Full Text Available The use of probiotics and synbiotics in the prevention and treatment of different disorders has dramatically increased over the last decade. Both probiotics and synbiotics are well known ingredients of functional foods and nutraceuticals and may provide beneficial health effects because they can influence the intestinal microbial ecology and immunity. The present study reviews the effects of probiotics and synbiotics on obesity, insulin resistance syndrome (IRS, type 2 diabetes (T2D and non-alcoholic fatty liver disease (NAFLD in human randomized clinical trials. Select probiotics and synbiotics provided beneficial effects in patients with obesity, mainly affecting the body mass index and fat mass. Some probiotics had beneficial effects on IRS, decreasing the cell adhesion molecule-1 levels, and the synbiotics decreased the insulin resistance and plasma lipid levels. Moreover, select probiotics improved the carbohydrate metabolism, fasting blood glucose, insulin sensitivity and antioxidant status and also reduced metabolic stress in subjects with T2D. Some probiotics and synbiotics improved the liver and metabolic parameters in patients with NAFLD. The oral intake of probiotics and synbiotics as co-adjuvants for the prevention and treatment of obesity, IRS, T2D and NAFLD is partially supported by the data shown in the present review. However, further studies are required to understand the precise mechanism of how probiotics and synbiotics affect these metabolic disorders.

  6. Effects of Probiotics and Synbiotics on Obesity, Insulin Resistance Syndrome, Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease: A Review of Human Clinical Trials.

    Science.gov (United States)

    Sáez-Lara, Maria Jose; Robles-Sanchez, Candido; Ruiz-Ojeda, Francisco Javier; Plaza-Diaz, Julio; Gil, Angel

    2016-06-13

    The use of probiotics and synbiotics in the prevention and treatment of different disorders has dramatically increased over the last decade. Both probiotics and synbiotics are well known ingredients of functional foods and nutraceuticals and may provide beneficial health effects because they can influence the intestinal microbial ecology and immunity. The present study reviews the effects of probiotics and synbiotics on obesity, insulin resistance syndrome (IRS), type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD) in human randomized clinical trials. Select probiotics and synbiotics provided beneficial effects in patients with obesity, mainly affecting the body mass index and fat mass. Some probiotics had beneficial effects on IRS, decreasing the cell adhesion molecule-1 levels, and the synbiotics decreased the insulin resistance and plasma lipid levels. Moreover, select probiotics improved the carbohydrate metabolism, fasting blood glucose, insulin sensitivity and antioxidant status and also reduced metabolic stress in subjects with T2D. Some probiotics and synbiotics improved the liver and metabolic parameters in patients with NAFLD. The oral intake of probiotics and synbiotics as co-adjuvants for the prevention and treatment of obesity, IRS, T2D and NAFLD is partially supported by the data shown in the present review. However, further studies are required to understand the precise mechanism of how probiotics and synbiotics affect these metabolic disorders.

  7. 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

  8. Probiotics for the treatment of upper and lower respiratory-tract infections in children: systematic review based on randomized clinical trials

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    Georgia Véras de Araujo

    2015-10-01

    Full Text Available ABSTRACT OBJECTIVES: Evaluate the effect of probiotics on the symptoms, duration of disease, and the occurrence of new episodes of upper and lower respiratory infections in healthy children. SOURCES: In order to identify eligible randomized controlled trials, two reviewers accessed four electronic databases [MEDLINE/PubMed, Scopus (Elsevier, Web of Science, and Cochrane (Cochrane VHL], as well as ClinicalTrials.gov until January 2015. Descriptors were determined by using the Medical Subject Headings tool, following the same search protocol. SUMMARY OF THE FINDINGS: Studies showed to be heterogeneous regarding strains of probiotics, the mode of administration, the time of use, and outcomes. The present review identified 11 peer-reviewed, randomized clinical trials, which analyzed a total of 2417 children up to 10 incomplete years of age. In the analysis of the studies, reduction in new episodes of disease was a favorable outcome for the use of probiotics in the treatment of respiratory infections in children. It is noteworthy that most of these studies were conducted in developed countries, with basic sanitation, health care, and strict, well-established and well-organized guidelines on the use of probiotics. Adverse effects were rarely reported, demonstrating probiotics to be safe. CONCLUSIONS: Despite the encouraging results - reducing new episodes of respiratory infections - the authors emphasize the need for further research, especially in developing countries, where rates of respiratory infections in children are higher when compared to the high per capita-income countries identified in this review.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  14. The effect of probiotic soy milk and soy milk on anthropometric measures and blood pressure in patients with type II diabetes mellitus: A randomized double-blind clinical trial

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    Mitra Hariri

    2015-04-01

    Full Text Available BACKGROUND: The objective of this clinical trial was to assess the effects of probiotic soy milk and soy milk on anthropometric measures and blood pressure (BP in type 2 diabetic (T2D patients. METHODS: A total of 40 patients with T2D, 35-68 years old, were assigned to two groups in this randomized, double-blind, controlled clinical trial. The patients in the intervention group consumed 200 ml/day of probiotic soy milk containing Lactobacillus planetarium A7 and those in control group consumed 200 ml/day of soy milk for 8 weeks. Anthropometric and BP measurements were performed according to standard protocols. For detecting within-group differences paired-sample t-tests was used and analysis of covariance was used for determining any differences between two groups. (The trial has been registered in the Iranian Registry of Clinical Trials, identifier: IRCT: IRCT201405265062N8. RESULTS: In this study, we failed to find any significant changes between probiotic soy milk and soy milk in term of body mass index (26.65 ± 0.68 vs. 26.33 ± 0.74, P = 0.300 and waist to hip ratio (1.49 ± 0.08 vs. 1.54 ± 0.1, P = 0.170. Although soy milk did not have any effect on BP, probiotic soymilk significantly decreased systolic (14.7 ± 0.48 vs. 13.05 ± 0.16, P = 0.001 and diastolic BP (10 ± 0.7 vs. 9.1 ± 1, P = 0.031. CONCLUSION: In our study, probiotic soy milk in comparing with soy milk did not have any beneficial effects on anthropometric measures in these patients. We need more clinical trial for confirming the effect of probiotic foods on anthropometric measure in diabetic patients. However, probiotic soy milk decreased systolic and diastolic BP significantly.   

  15. 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 ...

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

    Science.gov (United States)

    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.

  17. Mismatch between Probiotic Benefits in Trials versus Food Products.

    Science.gov (United States)

    Scourboutakos, Mary J; Franco-Arellano, Beatriz; Murphy, Sarah A; Norsen, Sheida; Comelli, Elena M; L'Abbé, Mary R

    2017-04-19

    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 searched for randomized controlled trials that tested the health effects of these strains in humans. There were six probiotic strains/strain combinations identified in the food supply. Thirty-one studies investigated these strains and found that they are associated with decreased diarrhea and constipation, improved digestive symptoms, glycemic control, antioxidant status, blood lipids, oral health, and infant breastfeeding outcomes, as well as enhanced immunity and support for Helicobacter pylori eradication. There were a limited number of studies investigating these strains. Many studies were funded by the food industry and tested dosages that were up to twenty-five times the dosage found in most food products. Probiotic food products could have health benefits not currently reported on their labels. However, many dosages are too low to provide the benefits demonstrated in clinical trials. Further research is needed to enable more effective use of these functional foods.

  18. Clinical Trials

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  1. Clinical Trials

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  2. 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.

    Science.gov (United States)

    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.

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  5. 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.

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

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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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  14. 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

    Directory of Open Access Journals (Sweden)

    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.

  15. 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.

    Science.gov (United States)

    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.

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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 ...

  1. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

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

    Directory of Open Access Journals (Sweden)

    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.

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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  4. 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.

    Science.gov (United States)

    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.

  5. 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, ...

  6. Probiotics

    Directory of Open Access Journals (Sweden)

    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

  7. 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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    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 ...

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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 ... 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 ...

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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 ... 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 ...

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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 ... 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 ... 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 ... well they work. The U.S. Food 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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    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 ... 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 ...

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

    Science.gov (United States)

    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

  20. Clinical Trials

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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 ... part. Randomization Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. This ...

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

    Directory of Open Access Journals (Sweden)

    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

  3. 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 ...

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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 ...

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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 ...

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    Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

  9. Clinical Trials

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    Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

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

    Directory of Open Access Journals (Sweden)

    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.

  12. 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.

    Science.gov (United States)

    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.

  13. [Microbiota in women; clinical applications of probiotics].

    Science.gov (United States)

    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.

  14. 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.

    Science.gov (United States)

    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.

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  5. Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial

    DEFF Research Database (Denmark)

    Hedayati-Hajikand, Trifa; Lundberg, Ulrika; Eldh, Catarina

    2015-01-01

    BACKGROUND: To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area. METHODS: The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138...... healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test group were instructed to give their child one chewing tablet per day containing three strains of live probiotic...... childhood caries development could be reduced through administration of these probiotic chewing tablets as adjunct to daily use of fluoride toothpaste in preschool children. Further studies on a possible dose-response relationship seem justified TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01720771...

  6. Clinical Trials

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    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  7. Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Pirbaglou, Meysam; Katz, Joel; de Souza, Russell J; Stearns, Jennifer C; Motamed, Mehras; Ritvo, Paul

    2016-09-01

    Gastrointestinal microbiota, consisting of microbial communities in the gastrointestinal tract, play an important role in digestive, metabolic, and immune functioning. Preclinical studies on rodents have linked behavioral and neurochemical changes in the central nervous system with deficits or alterations in these bacterial communities. Moreover, probiotic supplementation in rodents has been shown to markedly change behavior, with correlated changes in central neurochemistry. While such studies have documented behavioral and mood-related supplementation effects, the significance of these effects in humans, especially in relation to anxiety and depression symptoms, are relatively unknown. Thus, the purpose of this paper was to systematically evaluate current literature on the impact of probiotic supplementation on anxiety and depression symptoms in humans. To this end, multiple databases, including Medline, PsycINFO, PubMed, Scopus, and Web of Science were searched for randomized controlled trials published between January 1990 and January 2016. Search results led to a total of 10 randomized controlled trials (4 in clinically diagnosed and 6 in non-clinical samples) that provided limited support for the use of some probiotics in reducing human anxiety and depression. Despite methodological limitations of the included trials and the complex nature of gut-brain interactions, results suggest the detection of apparent psychological benefits from probiotic supplementation. Nevertheless a better understanding of developmental, modulatory, and metagenomic influences on the GI microbiota, specifically as they relate to mood and mental health, represent strong priorities for future research in this area. Copyright © 2016 Elsevier Inc. All rights reserved.

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

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    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

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    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

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    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

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  19. Effectiveness and safety of probiotic preparations in clinical treatment of inflammatory bowel disease

    Directory of Open Access Journals (Sweden)

    Ewa Wasilewska

    2018-03-01

    Full Text Available Inflammatory bowel disease (IBD is characterized by an aggressive immune response to luminal antigens including those of commensal microbiota, which are essential for intestinal homeostasis and appear to play a role in tolerance and immunity. Its disturbances can result in intestinal dysbiosis and the development of disease. The precise role of luminal bacteria in the pathogenesis of IBD has yet to be elucidated; however, considerable evidence implicates changes to bacterial communities associated with the gut mucosa in the disease state. It is also well known that beneficial microbes can confer a functional health benefit to the host. We analysed the effectiveness of probiotics to relieve symptoms in patients suffering from IBD. Using the Medline database and manually searching articles, we reviewed clinical trials performed with probiotics and lactic acid bacteria as supportive or alternative IBD treatments. The article summarizes IBD microenvironment and the efficiency of probiotic preparations in attenuating the symptoms of Crohn’s disease, ulcerative colitis, and pouchitis. The safety of probiotic intake is also analyzed based on existing outcomes of clinical trials and case reports. Strong evidence exists that probiotics are effective as supportive therapy for IBD; however, only a few preparations have well documented efficiency and safety. Clinical studies demonstrated that probiotics were more effective in preventing recurrence of the disease symptoms than in the management of its active stage. Some products may increase the risk of complications in specific patient groups; therefore, the use of probiotics should be considered with caution in the case of severe active IBD, especially with disrupted mucosa.

  20. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

    Science.gov (United States)

    Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

    2015-01-01

    Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

  1. 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.

  2. Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Joanna Harnett

    2016-01-01

    Full Text Available Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD. The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n=23 or 5 g placebo (n=22 orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011.

  3. 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

  4. Efficacy of Probiotic Escherichia coli Nissle 1917 in Patients with Irritable Bowel Syndrome: a Double Blind Placebocontrolled Randomized Trial

    Directory of Open Access Journals (Sweden)

    Amir H Faghihi

    2015-07-01

    Full Text Available Aim: to evaluate potential improvement effect for probiotic E. coliNissle 1917 in the management of refractory IBS in an Iranian population. Methods: a double blind placebo controlled approach as been used in the current clinical trial. 139 confirmed IBS patients were included into the study, and were given probiotic E.coli Nissle 1917 for 6 weeks. 11 items Birmingham IBS Symptom Questionnairehas been used for evaluation of changes in the symptoms every 2 weeks. Results: sixty eight subjects (49% were males. Mean±SD age of the participants was 38±13.3 years. 49(35.3% of the patients were diarrhea-predominant. The total scores showed no significant difference between the intervention vs. control group(-6.7±6.8 vs. -6.7±6.5, respectively; p=0.95; neither did any of the questionnaire items any significant alterations in the two groups. After stratification of patients based on their IBS type, diarrhea-predominant patients showed a positive response to the probiotic improving their sleep (p=0.05&0.03 at weeks 2&6, respectively. Patients with constipation-predominant IBS showed no response to the probiotic; while patients with diarrhea-constipation mixed IBS showed unfavorable response to the probiotic in the need for strain to pass a motion compared to the placebo (p=0.03&0.02 at weeks 4&6, respectively. Conclusion: probiotic therapy with E.coliNissle 1917 was not able to induce significant improvement in the symptoms of patients with non-categorized IBS. Nevertheless, when IBS patients were recategorized to subgroups according to their main symptoms, evaluation of the efficacy of the probiotic on some individual items in the symptom list reached the significance level. Prospective clinical trials are recommended to confirm our findings. Key words: probiotic Escherichia Coli Nissle 1917, irritable bowel syndrome, double blind randomized controlled trial.

  5. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  6. Clinical Trials

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    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  7. Clinical Trials

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    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  8. 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.

  9. Database and Bioinformatics Studies of Probiotics.

    Science.gov (United States)

    Tao, Lin; Wang, Bohua; Zhong, Yafen; Pow, Siok Hoon; Zeng, Xian; Qin, Chu; Zhang, Peng; Chen, Shangying; He, Weidong; Tan, Ying; Liu, Hongxia; Jiang, Yuyang; Chen, Weiping; Chen, Yu Zong

    2017-09-06

    Probiotics have been widely explored for health benefits, animal cares, and agricultural applications. Recent advances in microbiome, microbiota, and microbial dark matter research have fueled greater interests in and paved ways for the study of the mechanisms of probiotics and the discovery of new probiotics from uncharacterized microbial sources. A probiotics database named PROBIO was developed to facilitate these efforts and the need for the information on the known probiotics, which provides the comprehensive information about the probiotic functions of 448 marketed, 167 clinical trial/field trial, and 382 research probiotics for use or being studied for use in humans, animals, and plants. The potential applications of the probiotics data are illustrated by several literature-reported investigations, which have used the relevant information for probing the function and mechanism of the probiotics and for discovering new probiotics. PROBIO can be accessed free of charge at http://bidd2.nus.edu.sg/probio/homepage.htm .

  10. Clinical Trials

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    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  11. Clinical Trials

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    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  12. Clinical Trials

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    Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  13. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  14. Clinical Trials

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    Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...

  15. Clinical Trials

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    Full Text Available ... Sponsors also may stop a trial, or part of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ...

  16. Clinical trial: the effects of a fermented milk containing three probiotic bacteria in patients with irritable bowel syndrome - a randomized, double-blind, controlled study.

    Science.gov (United States)

    Simrén, M; Ohman, L; Olsson, J; Svensson, U; Ohlson, K; Posserud, I; Strid, H

    2010-01-15

    The effects of probiotic bacteria in IBS remain controversial. To study the effects of a probiotic product on IBS symptoms. We randomized 74 IBS patients to receive 8 weeks of daily treatment with 400 mL milk fermented with the yoghurt bacteria and containing Lactobacillus paracasei, ssp. paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 (Cultura; active) or acidified milk without these bacteria (control). The primary endpoint was the proportion of subjects reporting adequate relief of their IBS symptoms at least 50% of the weeks. IBS symptom severity, psychological symptoms and quality of life were assessed. The proportion of responders was 38% (14/37 patients) in the active group and 27% (10/37 patients) in the control group (P = 0.3). IBS symptom severity improved significantly in both groups during the treatment period. This change was greater in the active group during the first 2 weeks, but thereafter, no significant group differences were seen. We could not detect a clearly positive effect of fermented milk containing three probiotic bacteria on GI symptoms in IBS patients compared with the control treatment. However, a trend towards a more favourable effect during the first weeks was seen in the active group.

  17. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children

    Directory of Open Access Journals (Sweden)

    Grandy Giuseppe

    2010-08-01

    Full Text Available Abstract Background Evidence suggests that probiotics reduce rotavirus diarrhoea duration. Although there are several probiotic strains potentially useful, daily practice is often limited by the type and number of products locally available. In general, information about combined products is scarce. In this study we compare the effect of two probiotic products in the treatment of diarrhoea in children less than 2 years of age. Methods A Randomized double-blind controlled clinical trial in children hospitalized for acute rotavirus diarrhoea, in the Paediatric Centre Albina Patino, Cochabamba, Bolivia. Participants were children aged 1 - 23 months, who were randomly assigned to receive one of three treatments: Oral rehydration therapy plus placebo; Oral rehydration solution plus Saccharomyces boulardii; or Oral rehydration solution plus a compound containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii. Sample size was 20 per group and the outcomes were duration of diarrhoea, of fever, of vomiting and of hospitalization. Results 64 cases finished the protocol. On admission, patients' characteristics were similar. Median duration of diarrhoea (p = 0.04 in children who received the single species product (58 hours was shorter than in controls (84.5 hrs. Comparing children that received the single probiotic product and controls showed shorter duration of fever (18 vs 67 hrs (p = 0.0042 and the mixed probiotic of vomiting (0 vs 42.5 hrs (p = 0.041. There was no effect on duration of hospitalization (p = 0.31. When experimental groups were merged, statistical significance of changes increased (total duration of diarrhoea, fever and vomiting P = 0.025, P = 0.025 and P = 0.014, respectively. Conclusions Both products decreased the duration of diarrhoea compared to oral rehydration solution alone. This decrease was significant only for the single species product which also decreased the duration of

  18. Clinical Trials

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    Full Text Available ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers ...

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

    Science.gov (United States)

    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.

  1. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... How long will the trial last? Who will pay for the tests and treatments I receive? Will ...

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    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

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    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

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    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... a safety measure. They ensure a trial excludes any people for whom the protocol has known risks ...

  7. Clinical Trials

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    Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug ... life? Will I have to be in the hospital? How long will the trial last? Who will ...

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    Full Text Available ... procedures painful? What are the possible risks, side effects, and benefits of taking part in the study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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    Full Text Available ... Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

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    Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...

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    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...

  14. Clinical Trials

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    Full Text Available ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ... also was increasingly being used for prevention of heart disease.) The study found that HT increased the risk ...

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    Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...

  16. Clinical Trials

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    Full Text Available ... that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals with medically important questions ...

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    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ...

  18. Clinical Trials

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    Full Text Available ... treatment of menopausal symptoms. It also was increasingly being used for prevention of heart disease.) The study ... a trial are due to the different strategies being used, not to preexisting differences between the patients. ...

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  20. Understanding Clinical Trials

    Science.gov (United States)

    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.

  1. CREATION PRINCIPLES, MECHANISM OF ACTION AND CLINICAL APPLICATION OF PROBIOTICS

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

  3. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and ...

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    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about ... Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees ...

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ...

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    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

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    Full Text Available ... edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't ... of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ...

  8. Clinical Trials

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    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  9. Clinical Trials

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    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  11. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  12. A Gastroenterologist’s Guide to Probiotics

    Science.gov (United States)

    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

  13. Use of probiotics in the treatment of severe acute pancreatitis: a systematic review and meta-analysis of randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Introduction Necrotic tissue infection can worsen the prognosis of severe acute pancreatitis (SAP), and probiotics have been shown to be beneficial in reducing the infection rate in animal experiments and primary clinical trials. However, the results of multicenter randomized clinical trials have been contradictory. Our aim in this study was to systematically review and quantitatively analyze all randomized controlled trials with regard to important outcomes in patients with predicted SAP who received probiotics. Methods A systematic literature search of the PubMed, Embase and Cochrane Library databases was conducted using specific search terms. Eligible studies were randomized controlled trials that compared the effects of probiotic with placebo treatment in patients with predicted SAP. Mean difference (MD), risk ratio (RR) and 95% confidence interval (95% CI) were calculated using the Mantel-Haenszel fixed- and random-effects models. A meta-analysis on the use of probiotics in the treatment of critically ill patients was also performed to serve as a reference. Results In this study, 6 trials comprising an aggregate total of 536 patients were analyzed. Significant heterogeneities were observed in the type, dose, treatment duration and clinical effects of probiotics in these trials. Systematic analysis showed that probiotics did not significantly affect the pancreatic infection rate (RR = 1.19, 95% CI = 0.74 to 1.93; P = 0.47), total infections (RR = 1.09, 95% CI = 0.80 to 1.48; P = 0.57), operation rate (RR = 1.42, 95% CI = 0.43 to 3.47; P = 0.71), length of hospital stay (MD = 2.45, 95% CI = −2.71 to 7.60; P = 0.35) or mortality (RR = 0.72, 95% CI = 0.42 to 1.45; P = 0.25). Conclusions Probiotics showed neither beneficial nor adverse effects on the clinical outcomes of patients with predicted SAP. However, significant heterogeneity was noted between the trials reviewed with regard to the type, dose and

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

    Science.gov (United States)

    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.

  15. Clinical Trials

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    Full Text Available ... and useful results, which in turn will improve public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical ... Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

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    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

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    Full Text Available ... harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ... of research studies at the NIH Clinical Center, America's research hospital, located on the NIH campus in ...

  19. Clinical Trials

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    Full Text Available ... seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical ...

  20. Clinical Trials

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    Full Text Available ... the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If an approach seems ... Thus, research in humans is needed. For safety purposes, clinical ...

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  4. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

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

    Science.gov (United States)

    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.

  6. 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...

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

    Science.gov (United States)

    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.

  8. Research Areas - Clinical Trials

    Science.gov (United States)

    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.

  9. 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...

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

    Science.gov (United States)

    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

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

    DEFF Research Database (Denmark)

    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...

  12. 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,

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

    Directory of Open Access Journals (Sweden)

    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.

  14. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  15. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

  18. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  1. 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.

  2. Types of Cancer Clinical Trials

    Science.gov (United States)

    Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

  3. The Mexican consensus on probiotics in gastroenterology

    OpenAIRE

    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...

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

    Science.gov (United States)

    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.

  5. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  9. 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 ...

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

    Science.gov (United States)

    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.

  11. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  12. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  13. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  14. 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.

  15. Probiotics for the treatment of bacterial vaginosis.

    Science.gov (United States)

    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

  16. 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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  19. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

  20. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  1. Probiotics for photoprotection.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  4. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  7. Probiotics and Irritable Bowel Syndrome

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  9. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  10. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  11. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

  14. 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...

  15. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

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

    Directory of Open Access Journals (Sweden)

    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

  17. Probiotics: an update.

    Science.gov (United States)

    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.

  18. Probiotics: an update

    Directory of Open Access Journals (Sweden)

    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.

  19. [Clinical trials in nursing journals].

    Science.gov (United States)

    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.

  20. 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.

  1. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2006-10-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (-)-gossypol, 2-deoxyglucose, 3,4-DAP, 7-monohydroxyethylrutoside; Ad5CMV-p53, adalimumab, adefovir dipivoxil, ADH-1, alemtuzumab, aliskiren fumarate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, amrubicin hydrochloride, AN-152, anakinra, anecortave acetate, antiasthma herbal medicine intervention, AP-12009, AP-23573, apaziquone, aprinocarsen sodium, AR-C126532, AR-H065522, aripiprazole, armodafinil, arzoxifene hydrochloride, atazanavir sulfate, atilmotin, atomoxetine hydrochloride, atorvastatin, avanafil, azimilide hydrochloride; Bevacizumab, biphasic insulin aspart, BMS-214662, BN-83495, bortezomib, bosentan, botulinum toxin type B; Caspofungin acetate, cetuximab, chrysin, ciclesonide, clevudine, clofarabine, clopidogrel, CNF-1010, CNTO-328, CP-751871, CX-717, Cypher; Dapoxetine hydrochloride, darifenacin hydrobromide, dasatinib, deferasirox, dextofisopam, dextromethorphan/quinidine sulfate, diclofenac, dronedarone hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Edaravone, efaproxiral sodium, emtricitabine, entecavir, eplerenone, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, ezetimibe, ezetimibe/simvastatin; Finrozole, fipamezole hydrochloride, fondaparinux sodium, fulvestrant; Gabapentin enacarbil, gaboxadol, gefitinib, gestodene, ghrelin (human); Human insulin, human papillomavirus vaccine; Imatinib mesylate, immunoglobulin intravenous (human), indiplon, insulin detemir, insulin glargine, insulin glulisine, intranasal insulin, istradefylline, i.v. gamma

  2. Comparison of Two Forms of Loperamide-Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial.

    Science.gov (United States)

    Cottrell, Jeremy; Koenig, Kerstin; Perfekt, Roland; Hofmann, Robert

    2015-12-01

    Acute diarrhoea is a frequent health problem in both travellers and residents that has a social and economic impact. This study compared the efficacy and tolerability of two loperamide-simeticone formulations and a Saccharomyces boulardii capsule as symptomatic treatment. This was a prospective, randomised, single (investigator)-blind, three-arm, parallel group, non-inferiority clinical trial in adult subjects with acute diarrhoea at clinics in Mexico and India, with allocation to a loperamide-simeticone 2/125 mg caplet or chewable tablet (maximum eight in 48 h) or S. boulardii (250 mg twice daily for 5 days). The primary outcome measure was the number of unformed stools between 0 and 24 h following the initial dose of study medication (NUS 0-24). The secondary outcome measures were time to last unformed stool (TLUS), time to complete relief of diarrhoea (TCRD), time to complete relief of abdominal discomfort (TCRAD) and the subject's evaluation of treatment effectiveness. Follow-up endpoints at 7 days were feeling of complete wellness; stool passed since final study visit; and continued or recurrent diarrhoea. In this study, 415 subjects were randomised to either a loperamide-simeticone caplet (n = 139), loperamide-simeticone chewable tablet (n = 139) or S. boulardii capsule (n = 137) and were included in the intention-to-treat analysis. With regards to mean NUS 0-24, the loperamide-simeticone caplet was non-inferior to loperamide-simeticone tablets (3.4 vs. 3.3; one-sided 97.5 % confidence interval ≤0.5), with both significantly lower than S. boulardii (4.3; p boulardii); p boulardii. Treatment effectiveness for overall illness, diarrhoea and abdominal discomfort relief was greater (p boulardii. At 7-day follow-up most subjects reported passing stool at least once since the final study visit (loperamide-simeticone caplet 94.1 %, loperamide-simeticone chewable tablet 94.8 %, S. boulardii 97.0 %), did not experience continued or recurrent diarrhoea [loperamide

  3. Systematic review: probiotics for functional constipation in children.

    Science.gov (United States)

    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.

  4. Probiotics for people with hepatic encephalopathy.

    Science.gov (United States)

    Dalal, Rohan; McGee, Richard G; Riordan, Stephen M; Webster, Angela C

    2017-02-23

    Hepatic encephalopathy is a disorder of brain function as a result of liver failure or portosystemic shunt or both. Both hepatic encephalopathy (clinically overt) and minimal hepatic encephalopathy (not clinically overt) significantly impair patient's quality of life and daily functioning, and represent a significant burden on healthcare resources. Probiotics are live micro-organisms, which when administered in adequate amounts, may confer a health benefit on the host. To determine the beneficial and harmful effects of probiotics in any dosage, compared with placebo or no intervention, or with any other treatment for people with any grade of acute or chronic hepatic encephalopathy. This review did not consider the primary prophylaxis of hepatic encephalopathy. We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, conference proceedings, reference lists of included trials, and the World Health Organization International Clinical Trials Registry Platform until June 2016. We included randomised clinical trials that compared probiotics in any dosage with placebo or no intervention, or with any other treatment in people with hepatic encephalopathy. We used standard methodological procedures expected by The Cochrane Collaboration. We conducted random-effects model meta-analysis due to obvious heterogeneity of participants and interventions. We defined a P value of 0.05 or less as significant. We expressed dichotomous outcomes as risk ratio (RR) and continuous outcomes as mean difference (MD) with 95% confidence intervals (CI). We included 21 trials with 1420 participants, of these, 14 were new trials. Fourteen trials compared a probiotic with placebo or no treatment, and seven trials compared a probiotic with lactulose. The trials used a variety of probiotics; the most commonly used group of probiotic was VSL#3, a proprietary name for a group of eight probiotics. Duration of administration

  5. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  6. 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...

  7. 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.

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

    Science.gov (United States)

    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.

  9. Probiotics-mediated suppression of cancer.

    Science.gov (United States)

    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.

  10. Social media in clinical trials.

    Science.gov (United States)

    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.

  11. 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.

  12. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

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

    OpenAIRE

    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 ...

  14. 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.

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

    Science.gov (United States)

    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.

  16. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  17. 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.

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

  19. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

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

    Science.gov (United States)

    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.

  6. Probiotics and necrotizing enterocolitis.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  8. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2018-04-01

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  9. 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

  10. 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.

  11. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

  12. Probiotics in Clostridium difficile infection: reviewing the need for a multistrain probiotic.

    Science.gov (United States)

    Hell, M; Bernhofer, C; Stalzer, P; Kern, J M; Claassen, E

    2013-03-01

    In the past two years an enormous amount of molecular, genetic, metabolomic and mechanistic data on the host-bacterium interaction, a healthy gut microbiota and a possible role for probiotics in Clostridium difficile infection (CDI) has been accumulated. Also, new hypervirulent strains of C. difficile have emerged. Yet, clinical trials in CDI have been less promising than in antibiotic associated diarrhoea in general, with more meta-analysis than primary papers on CDI-clinical-trials. The fact that C. difficile is a spore former, producing at least three different toxins has not yet been incorporated in the rational design of probiotics for (recurrent) CDI. Here we postulate that the plethora of effects of C. difficile and the vast amount of data on the role of commensal gut residents and probiotics point towards a multistrain mixture of probiotics to reduce CDI, but also to limit (nosocomial) transmission and/or endogenous reinfection. On the basis of a retrospective chart review of a series of ten CDI patients where recurrence was expected, all patients on adjunctive probiotic therapy with multistrain cocktail (Ecologic®AAD/OMNiBiOTiC® 10) showed complete clinical resolution. This result, and recent success in faecal transplants in CDI treatment, are supportive for the rational design of multistrain probiotics for CDI.

  13. Probiotics for caries prevention and control

    DEFF Research Database (Denmark)

    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...

  14. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  15. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  16. Clinical Effect of IRT-5 Probiotics on Immune Modulation of Autoimmunity or Alloimmunity in the Eye

    Directory of Open Access Journals (Sweden)

    Jaeyoung Kim

    2017-10-01

    eye model. Conclusion: Our results suggest that administration of IRT-5 probiotics may modulate clinical manifestations of autoimmunity in the eye, but not on alloimmunity of corneal transplantation.

  17. 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.

  18. The Mexican consensus on probiotics in gastroenterology.

    Science.gov (United States)

    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.

  19. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  1. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  2. Tolerogenic probiotics: potential immunoregulators in Systemic Lupus Erythematosus.

    Science.gov (United States)

    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.

  3. 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...

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  6. 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....

  7. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  8. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  9. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  10. NCI National Clinical Trials Network Structure

    Science.gov (United States)

    Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

  11. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  12. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  13. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

  16. 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.

  17. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  18. Probiotic yogurt improves antioxidant status in type 2 diabetic patients.

    Science.gov (United States)

    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.

  19. Where are clinical trials going? Society and clinical trials.

    Science.gov (United States)

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

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

    Directory of Open Access Journals (Sweden)

    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

  1. Probiotics, calcium and acute diarrhea : a randomized trial in Indonesian children

    NARCIS (Netherlands)

    Agustina, R.

    2012-01-01

    Background
    Acute diarrhea and acute respiratory tract infections (ARTIs) continue to lead the infectious cause of morbidity and mortality among children <5 years of age in developing countries, including Indonesia. Efforts to prevent diarrheal disease by probiotics and milk calcium

  2. 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.

  3. Credentialing for participation in clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  6. Clinical trials and gender medicine.

    Science.gov (United States)

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  7. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  8. 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.

  9. Gut microbiota and probiotics: Focus on diabetes mellitus.

    Science.gov (United States)

    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.

  10. 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.

  11. Probiotics are effective in alleviating infantile colic; results of a randomized controlled trial held at benazir bhutto hospital rawalpindi, pakistan

    International Nuclear Information System (INIS)

    Ashraf, M.W.; Ayaz, S.B.; Ashraf, M.N.

    2015-01-01

    Objectives: This study aimed to assess the role of probiotics in alleviating infantile colic (IC) while targeting local population. In case of a positive outcome, its use could be suggested in pediatric health care facilities. Methodology: It was a non-blinded randomized control trial conducted at the department of pediatrics, Benazir Bhutto Hospital, Rawalpindi from 4th October 2012 to 3rd April 2013. Through non-probability consecutive sampling we included breast-fed infants of either sex of age 3 weeks (21 days) to 3 months (90 days) diagnosed with IC based on Wessel description. We divided them into two groups i.e. group-A and B who were given probiotics containing Lactobacillus reuteri and simethicone respectively. Results: Of 90 children, 45 children were in each group. Group-A had a mean age 48 ± 17 days and group-B had a mean age 50 ± 17 days. Maximum infants were in sub-group 21 - 45 days (55.6% and 51.1% respectively) in both the groups. The male gender dominated both groups (64.4% and 57.7% respectively). Significantly large percentage (p<0.001) of infants in group-A (86.7%) reached the landmark set for the efficacy confirmation than group-B (51.1%). The mean crying time for the group-A (39 ± 53 minutes) at the end of treatment was significantly shorter (p<0.001) than that of group-B (113 ± 54 minutes). No side effect was reported in the whole sample. Conclusion: Probiotics containing Lactobacillus reuteri significantly improved symptoms in managing IC than simethicaone with no side effects. (author)

  12. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

  15. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... Info Lines Health Services Locator HealthCare.gov NIH Clinical Research Trials and You Talking to Your Doctor Science ... Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation and Guidance More » Quick Links ...

  16. Probiotics as Antifungals in Mucosal Candidiasis.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  3. 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.

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  7. 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

  8. 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.

  9. Probiotics as an adjuvant treatment in Helicobacter pylori eradication therapy.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  11. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  12. Probiotics in management of hepatic encephalopathy.

    Science.gov (United States)

    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.

  13. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Probiotics in dermatologic practice.

    Science.gov (United States)

    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.

  15. Probiotic Supplementation in Chronic Kidney Disease: A Double-blind, Randomized, Placebo-controlled Trial.

    Science.gov (United States)

    Borges, Natália A; Carmo, Flávia L; Stockler-Pinto, Milena B; de Brito, Jessyca S; Dolenga, Carla J; Ferreira, Dennis C; Nakao, Lia S; Rosado, Alexandre; Fouque, Denis; Mafra, Denise

    2018-01-01

    The objective of the study was to evaluate the effects of probiotic supplementation on the gut microbiota profile and inflammatory markers in chronic kidney disease patients undergoing maintenance hemodialysis (HD). This was a randomized, double-blind, placebo-controlled study. Forty-six HD patients were assigned to receive 1 of 2 treatments: probiotic (n = 23; Streptococcus thermophilus, Lactobacillus acidophilus e Bifidobacterialongum, 90 billion colony-forming units per day) or placebo (n = 23) daily for 3 months. Blood and feces were collected at baseline and after intervention. The inflammatory markers (C-reactive protein and interleukin-6) were analyzed by immunoenzymatic assay (enzyme-linked immunosorbent assay). Uremic toxins plasma levels (indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid) were obtained by Reversed-Phase High-Performance Liquid Chromatography. Routine laboratory parameters were measured by standard techniques. Fecal pH was measured by the colorimetric method, and the gut microbiota profile was assessed by Denaturing Gradient Gel Electrophoresis analysis. Sixteen patients remained in the probiotic group (11 men, 53.6 ± 11.0 year old, 25.3 ± 4.6 kg/m 2 ) and 17 in the placebo group (10 men, 50.3 ± 8.5 year old, 25.2 ± 5.7 kg/m 2 ). After probiotic supplementation there was a significant increase in serum urea (from 149.6 ± 34.2 mg/dL to 172.6 ± 45.0 mg/dL, P = .02), potassium (from 4.4 ± 0.4 mmol/L to 4.8 ± 0.4 mmol/L, P = .02), and indoxyl sulfate (from 31.2 ± 15.9 to 36.5 ± 15.0 mg/dL, P = .02). The fecal pH was reduced from 7.2 ± 0.8 to 6.5 ± 0.5 (P = .01). These parameters did not change significantly in placebo group. Changes in the percentage delta (Δ) between groups were exhibited with no statistical differences observed. The inflammatory markers and gut profile were not altered by supplementation. Aprobiotic supplementation failed to reduce uremic toxins and

  16. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

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

    Directory of Open Access Journals (Sweden)

    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.

  18. Inherited Retinal Degenerative Clinical Trial Network

    Science.gov (United States)

    2009-10-01

    clinical efforts that will impact the NEER network going forward and laid the ground work for the CTECs to participate in ongoing clinical trials for...Clinical Implications: • How will the proposed clinical trial have a significant impact on disease outcome? 34 • How will the clinical trial offer...was 0 041U>< for pat<t!nts NPtS and <H08, 0 4 1ux !01 Ct 110, 1nd 10.0 lux f01 < H13 OJ)Ilo •her on~tion are indiuttd AhtrNtor19 stimuli Wl’f1! pres

  19. 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.

  20. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    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.

  1. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  2. Inherited Retinal Degenerative Clinical Trial Network. Addendum

    Science.gov (United States)

    2013-10-01

    inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD) through the conduct of clinical trials and other...design and conduct of effective and efficient clinical trials for inherited orphan retinal degenerative diseases and dry AMD; • Limited number and...linica l trial in the NEER network for autosomal dominant retinitis pigmentosa, and the ProgSTAR studies for Stargardt disease ) . As new interventions b

  3. 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

  4. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    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 c...

  5. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  6. Methodology Series Module 4: Clinical Trials.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  7. Best clinical trials reported in 2010.

    Science.gov (United States)

    Garner, John B; Grayburn, Paul A; Yancy, Clyde W

    2011-07-01

    Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

  10. Probiotics and down-regulation of the allergic response.

    Science.gov (United States)

    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.

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

    OpenAIRE

    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 ...

  12. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-04-08

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

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

    Science.gov (United States)

    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.

  14. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

    Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

  15. clinical trials of Sutherlandia frutescens

    African Journals Online (AJOL)

    economic and political imperatives surrounding randomised controlled trials and the ambiguous, or even ..... the medicinal properties of the plant, as reported both in the book, and also in the .... London, UK: Harvard University Press. Latour, B.

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

    Science.gov (United States)

    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.

  17. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  18. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

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

    Science.gov (United States)

    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.

  20. Problematic trial detection in ClinicalTrials.gov

    NARCIS (Netherlands)

    Hartgerink, C.H.J.; George, Stephen

    2015-01-01

    Clinical trials are crucial in determining the effectiveness of treatments and directly affect clinical and policy decisions. These decisions are undermined if the data are problematic due to data fabrication or other errors. Researchers have worked on developing statistical methods to detect

  1. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  2. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  3. Clinical trial data analysis using R

    National Research Council Canada - National Science Library

    Chen, Ding-Geng; Peace, Karl E

    2011-01-01

    .... Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R...

  4. Overcoming Age Limits in Cancer Clinical Trials

    Science.gov (United States)

    Adolescents, young adults, and the elderly lag far behind other age groups when it comes to enrolling in clinical trials. Their participation is critical to advancing effective therapies for these age groups.

  5. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  6. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... The US database, on the other hand, clearly identifies 172 ... operating within extended clinical trials R&D value chains. Companies often ... Source: CeSTII Survey Management and Results System internal database. Table III.

  7. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  8. Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lee, Bonsan Bonne; Toh, Swee-Ling; Ryan, Suzanne; Simpson, Judy M; Clezy, Kate; Bossa, Laetitia; Rice, Scott A; Marial, Obaydullah; Weber, Gerard; Kaur, Jasbeer; Boswell-Ruys, Claire; Goodall, Stephen; Middleton, James; Tudehope, Mark; Kotsiou, George

    2016-04-16

    with SCI. The primary outcome will be analysed using survival analysis of factorial groups, with Cox regression modelling to test the effect of each treatment while allowing for the other, assuming no interaction effect. Hazard ratios and Kaplan-Meier survival curves will be used to summarise results. If these probiotics are shown to be effective in preventing UTI and MRO colonisation, they would be a very attractive alternative for UTI prophylaxis and for combating the increasing rate of antibiotic resistance after SCI. Australian New Zealand Clinical Trials Registry [ ACTRN 12610000512022 ]. Date of registration: 21 June 2010.

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

    Science.gov (United States)

    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.

  10. 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

  11. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  12. Clinical efficacy of probiotic mouthwash in the treatment of gingivitis patients in Himachal population

    Directory of Open Access Journals (Sweden)

    Vikas Jindal

    2017-01-01

    Full Text Available This study was conducted to analyze the changes in gingival health in patients treated with probiotic containing mouth rinse. Thirty volunteers between 20 and 35 years were randomly divided into two groups. While one group was given placebos, the other was given probiotic mouth rinse for 14 days. The volunteers were instructed to swish the mouth rinse for 60 s twice a day. Intergroup comparison of the plaque scores (baseline-14 days showed there was statistically significant difference in the mean plaque scores between the placebos group (0.14 (P ≤ 0.05 and the test group (0.42 (P ≤ 0.05 and a statistically significant difference in the mean gingival scores from baseline-14 days between the placebos group (0.9 (P ≤ 0.05 and the test group (0.38 with (P ≤ 0.05. Despite the short period for which the probiotics mouthwash was used by the patients, substantial improvement in gingival health of patients was observed in the study.

  13. 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.

  14. 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.

  15. 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

  16. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  17. 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

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

    Directory of Open Access Journals (Sweden)

    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

  19. Use of Probiotics as Prophylaxis for Postoperative Infections

    Directory of Open Access Journals (Sweden)

    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

  20. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

    National Research Council Canada - National Science Library

    Kaplan, Celia P

    2007-01-01

    .... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...

  1. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  2. Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

    Science.gov (United States)

    Patrick-Lake, Bray

    2018-02-01

    Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

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

    Science.gov (United States)

    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.

  4. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

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

    Science.gov (United States)

    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.

  6. Probiotics and Treatment of Vulvovaginal Candidiasis

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  8. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  9. Quality of clinical trials: A moving target

    Science.gov (United States)

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  10. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  11. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  14. Update on clinical trials in Dysphagia.

    Science.gov (United States)

    Logemann, Jeri A

    2006-04-01

    Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described.

  15. Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial.

    Science.gov (United States)

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

    2015-01-01

    The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4-6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag(®), or a placebo (one capsule for seven consecutive days vaginally). The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Administration of inVag contributed to a significant decrease (between visits) in both vaginal pH (Pvaginal microbiota, as demonstrated by predominance of the Lactobacillus bacteria in vaginal microbiota.

  16. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  17. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial

    Science.gov (United States)

    2018-03-23

    Ventilator Associated Pneumonia (VAP); Other Infections; Antibiotic-Associated Diarrhea; C-Difficile; Duration of Mechanical Ventilation; Length of ICU Stay; Length of Hospital Stay; ICU and Hospital Mortality

  18. Genomic sequencing in clinical trials

    OpenAIRE

    Mestan, Karen K; Ilkhanoff, Leonard; Mouli, Samdeep; Lin, Simon

    2011-01-01

    Abstract Human genome sequencing is the process by which the exact order of nucleic acid base pairs in the 24 human chromosomes is determined. Since the completion of the Human Genome Project in 2003, genomic sequencing is rapidly becoming a major part of our translational research efforts to understand and improve human health and disease. This article reviews the current and future directions of clinical research with respect to genomic sequencing, a technology that is just beginning to fin...

  19. Clinical trials in male hormonal contraception.

    Science.gov (United States)

    Nieschlag, Eberhard

    2010-11-01

    Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. Copyright © 2010 Elsevier Inc. All rights reserved.

  20. Efficacy of Probiotics Versus Placebo in the Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants: A Double-blind Randomized Controlled Trial

    International Nuclear Information System (INIS)

    Chowdhury, T.; Ali, M.M.; Hossain, M. M.

    2016-01-01

    Objective: To evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis (NEC) in preterm very low birth weight (VLBW) infants. Study Design: Arandomized double blind controlled trial. Place and Duration of Study: The Paediatrics Department of Sylhet M.A.G. Osmani Medical College Hospital, Sylhet Bangladesh, from July 2012 to June 2015. Methodology: Preterm (28 - 33 weeks gestation) VLBW (birth weight 1000 - 1499 g) neonates were enrolled. The study group was fed with probiotics once daily with breast milk from first feeding, and the control group with only breast milk without the addition of probiotics. Both the groups received other standard care. The primary outcome was the development of NEC (stage II and III), categorized by modified Bell's classification. Result: In 108 neonates, development of NEC was significantly lower in the study group than that of control group [1 (1.9 percent) vs. 6 (11.5 percent); p=0.044]. Age of achievement of full oral feeding was significantly earlier in the study group than that in the control group (14.88 ±3.15 and 18.80 ±4.32 days; p < 0.001). Duration of hospital stay was significantly short in the study group compared to the control group (15.82 ±2.94 days vs. 19.57 ±4.26 days; p < 0.001). Conclusion: Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight. It is also associated with faster achievement of full oral feeding and short duration of hospital stay. (author)

  1. Probiotics for vulvovaginal candidiasis in non-pregnant women.

    Science.gov (United States)

    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

  2. Probiotics and prebiotics in dermatology.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

  4. 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.

  5. A randomized controlled trial to test the effect of multispecies probiotics on cognitive reactivity to sad mood.

    Science.gov (United States)

    Steenbergen, Laura; Sellaro, Roberta; van Hemert, Saskia; Bosch, Jos A; Colzato, Lorenza S

    2015-08-01

    Recent insights into the role of the human microbiota in cognitive and affective functioning have led to the hypothesis that probiotic supplementation may act as an adjuvant strategy to ameliorate or prevent depression. Heightened cognitive reactivity to normal, transient changes in sad mood is an established marker of vulnerability to depression and is considered an important target for interventions. The present study aimed to test if a multispecies probiotic containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, and Lactococcus lactis (W19 and W58) may reduce cognitive reactivity in non-depressed individuals. In a triple-blind, placebo-controlled, randomized, pre- and post-intervention assessment design, 20 healthy participants without current mood disorder received a 4-week probiotic food-supplement intervention with the multispecies probiotics, while 20 control participants received an inert placebo for the same period. In the pre- and post-intervention assessment, cognitive reactivity to sad mood was assessed using the revised Leiden index of depression sensitivity scale. Compared to participants who received the placebo intervention, participants who received the 4-week multispecies probiotics intervention showed a significantly reduced overall cognitive reactivity to sad mood, which was largely accounted for by reduced rumination and aggressive thoughts. These results provide the first evidence that the intake of probiotics may help reduce negative thoughts associated with sad mood. Probiotics supplementation warrants further research as a potential preventive strategy for depression. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  7. Infrastructure for Clinical Trials in Duchenne Dystrophy

    Science.gov (United States)

    2010-09-13

    A Zimmerman, T Duong, J Florence and the CINRG Investigators. Pulmonary Function Characteristics of Boys with Duchenne and Becker Muscular Dystrophy ...designated CINRG site staff 1. Has the participant been clinically diagnosed with Limb-Girdle or Becker muscular dystrophy ? LGMD BMD 2. Was...Number: W81XWH-09-1-0592 TITLE: CINRG: Infrastructure for Clinical Trials in Duchenne Dystrophy PRINCIPAL INVESTIGATOR: Avital Cnaan, PhD

  8. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. Published by Elsevier Inc.

  9. Lung Cancer Clinical Trials: Advances in Immunotherapy

    Science.gov (United States)

    New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.

  10. Quality assurance of asthma clinical trials.

    Science.gov (United States)

    Malmstrom, Kerstin; Peszek, Iza; Al Botto; Lu, Susan; Enright, Paul L; Reiss, Theodore F

    2002-04-01

    Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.

  11. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... companies to manufacture pharmaceuticals, 24 to carry out quality control and ... represents a 3% real growth from 2004/2005, it represents a slight decline from ... manufacturer for the pharmas, or can it leverage strengths in medical ... increased clinical trials activity, R&D investment is too low to make it a ...

  12. Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...

    African Journals Online (AJOL)

    Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...

  13. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  14. Clinical trial quality: From supervision to collaboration and beyond.

    Science.gov (United States)

    Meeker-O'Connell, Ann; Glessner, Coleen

    2018-02-01

    Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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

  17. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  18. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  19. [Ethical principles of clinical trials in minors].

    Science.gov (United States)

    Koch, H J; Raschka, C

    2002-12-05

    Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

  20. New EORTC clinical trials for BNCT

    International Nuclear Information System (INIS)

    Hideghety, K.; Moss, R.; Vries, M. de

    2000-01-01

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  1. Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Tomusiak A

    2015-09-01

    Full Text Available Anna Tomusiak,1 Magdalena Strus,1 Piotr B Heczko,1 Paweł Adamski,2 Grzegorz Stefański,3 Aleksandra Mikołajczyk-Cichońska,3 Magdalena Suda-Szczurek3 1Department of Microbiology, Jagiellonian University Medical College, 2Institute of Nature Conservation, Polish Academy of Sciences, 3IBSS BIOMED SA, Kraków, Poland Objective: The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. Patients and methods: The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4–6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag®, or a placebo (one capsule for seven consecutive days vaginally. The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Results: Administration of inVag contributed to a significant decrease (between visits in both vaginal pH (P<0.05 and Nugent score (P<0.05, and a significant increase in the abundance of Lactobacillus between visit I and visits III and IV (P<0.05. Molecular typing revealed the presence of Lactobacillus strains originating from inVag in 82% of women taking the drug at

  2. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ahmadi, Shahnaz; Jamilian, Mehri; Karamali, Maryam; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah

    2017-12-01

    The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n = 30) or placebo (n = 30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 ± 0.4 vs. +0.1 ± 1.0 kg, p = 0.004) and BMI (-0.2 ± 0.2 vs. +0.03 ± 0.4 kg/m 2 , p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p = 0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.

  3. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored. Published by Elsevier Inc.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  6. 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 ...

  7. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. © The Author(s) 2015.

  8. Activating clinical trials: a process improvement approach.

    Science.gov (United States)

    Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

    2016-02-24

    The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength

  9. Clinical trials integrity: a CRO perspective.

    Science.gov (United States)

    Beach, J E

    2001-01-01

    When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

  10. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  11. Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

    2018-03-01

    Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  12. 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.

  13. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

    Directory of Open Access Journals (Sweden)

    Rachel G. Greenberg

    2018-03-01

    In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  14. 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.

  15. 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.

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

    Science.gov (United States)

    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.

  17. Recent clinical trials in valvular heart disease.

    Science.gov (United States)

    Kiss, Daniel; Anwaruddin, Saif

    2017-07-01

    With widespread adoption of transcatheter aortic valve replacement, there has been a change in the approach to management of valvular heart disease. New interest has taken hold in transcatheter therapies for valvular heart disease, as well as research into pathophysiology and progression of disease. Additionally, several key trials have further refined our understanding of surgical management of valvular heart disease. This review will elucidate recent clinical trial data leading to changes in practice. There have been several landmark trials expanding the indications for transcatheter aortic valve replacement. Additionally, although still early, trials are beginning to demonstrate the feasibility and safety of transcatheter mitral valves. Options for transcatheter management of right-sided valvular disease continue to evolve, and these are areas of active investigation. The emergence of novel therapies for valvular heart disease has expanded the management options available, allowing physicians to better individualize treatment of patients with valvular heart disease. This review will focus on the recent (within 2 years) trials in this field of interest.

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

    Science.gov (United States)

    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.

  19. Double blind, placebo controlled trial of two probiotic strains in interleukin 10 knockout mice and mechanistic link with cytokine balance

    NARCIS (Netherlands)

    McCarthy, J.; O'Mahony, L.; O'Callaghan, L.; Sheil, B.; Vaughan, E.E.; Fitzsimons, N.A.; Fitzgibbon, J.; O'Sullivan, G.C.; Kiely, B.; Collins, J.K.; Shanahan, F.

    2003-01-01

    Background: Prophylactic efficacy against colitis following lactobacillus consumption in interleukin 10 (IL-10) knockout ( KO) mice has been reported. Whether this applies equally to other probiotic strains is unknown, and the mechanism is unclear. Aims: ( 1) To compare the effect of feeding

  20. A randomized controlled trial to test the effect of multispecies probiotics on cognitive reactivity to sad mood

    NARCIS (Netherlands)

    Steenbergen, L.; Sellaro, R.; van Hemert, S.; Bosch, J.A.; Colzato, L.S.

    2015-01-01

    Background: Recent insights into the role of the human microbiota in cognitive and affective functioning have led to the hypothesis that probiotic supplementation may act as an adjuvant strategy to ameliorate or prevent depression. Objective: Heightened cognitive reactivity to normal, transient