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Irritable Bowel Syndrome | Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome

Irritable Bowel Syndrome research study

What is the primary objective of this study?

Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology. Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?

Who is eligible to participate?

Inclusion Criteria: - Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome. - Age between 18- 60 years. - Male and female both. - Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years. - All Patients need to satisfy ROME III criteria Exclusion Criteria: - Age < 18 and > 60 years - Pregnant and lactating females - Patients on laxatives or antidiarrheal drugs that could influence the motility of gut - Patient on antibiotics or within 2 weeks of starting protocol. - Not willing to participate - Non-compliant in run in period. - Patients taking Husk. - Diabetic patients

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Irritable Bowel Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Saccharomyces boulardii250mg, twice a day in sachets, for 8 weeks

Drug:Methyl cellulose powder (low viscosity)twice a day sachets for 10 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.

2Placebo will be given twice a day for 10 weeks

Study Status

Unknown status

Start Date: October 2007

Completed Date: July 2008

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence

Secondary Outcome: Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.

Study sponsors, principal investigator, and references

Principal Investigator: Lubna Kamani, FCPS,MRCP

Lead Sponsor: Aga Khan University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00543478

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