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| Sponsors and Collaborators: |
Aga Khan University Biocodex |
|---|---|
| Information provided by: | Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT00589771 |
Purpose
Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea Dominant Irritable Bowel Syndrome |
Drug: Saccharomyces boulardii Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome |
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Capsule Saccharomyces boulardii 250 mg TDS
|
Drug: Saccharomyces boulardii
Saccharomyces boulardii one capsule 250mg BD for 6 weeks
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B: Placebo Comparator
Capsule Placebo TDS
|
Drug: Placebo
Cap Placebo TDS for six weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Pakistan, Sindh | |
| Aga Khan University Hospital | |
| Karachi, Sindh, Pakistan, 74800 | |
| Principal Investigator: | Zaigham Abbas, FACG | Aga Khan University HOSPITAL |
More Information
| Responsible Party: | Aga Khan University ( Zaigham Abbas ) |
| Study ID Numbers: | 674- MED, 2007-674MED-ERC, SB-IBS-674, SB-IBS-cytokines-674 |
| Study First Received: | December 26, 2007 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00589771 History of Changes |
| Health Authority: | Pakistan: Research Ethics Committee |
|
IBS Saccharomyces boulardii probiotics |
cytokine histology Efficacy |
|
Signs and Symptoms Digestive System Diseases Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases |
Colonic Diseases Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
|
Signs and Symptoms Pathologic Processes Disease Digestive System Diseases Diarrhea Signs and Symptoms, Digestive |
Gastrointestinal Diseases Syndrome Colonic Diseases Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
