NCT00543478

Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome

Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

Irritable bowel syndrome (IBS) is a common functional disorder and may lead to impaired social and personal function and can diminish quality of life.While the precise pathophysiology of IBS remains to be elucidated, dysmotility and altered visceral sensory perception are currently the most popular hypothesis. There has been a suggestion that some patients with IBS may harbor bacterial overgrowth leading to low grade inflammation, immune activation, and their symptoms may be ameliorated by its eradication.Probiotics, defined as live or attenuated bacteria or micro organism that confer a significant health benefit to the host. * I. Firstly, probiotic organism exert antibacterial and antiviral effects. * II. Probiotics could alter the composition of the gut flora, either directly through augmentation of commensal or indirectly through a reduction in pathogen related inflammation or bacterial fermentation. Trial protocol: Phase 1: placebo BID (1 week),both arms Phase 2: Randomization by pharmacy, placebo vs. active drug (6 weeks) Phase 3: placebo BID (1 week), both arms -III. Probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces by reducing mucosal inflammation, decreasing immune mediated activation of enteric motor and sensory neurons and modifying neural traffic between the gut and central nervous system. Saccharomyces Boulardii is a probiotic yeast and its role for the treatment of IBS has not been extensively investigated.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Saccharomyces boulardii	250mg, twice a day in sachets, for 8 weeks
DRUG	Methyl cellulose powder (low viscosity)	twice a day sachets for 10 weeks

Timeline

• Start date: 2007-10-01
• Completion: 2008-07-01
• First posted: 2007-10-15
• Last updated: 2007-10-15

Locations

1 site across 1 country: Pakistan