NCT00589771

Saccharomyces Boulardii in Irritable Bowel Syndrome

Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Diarrhea Dominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Saccharomyces boulardii	1. Saccharomyces boulardii one capsule 250mg TDS for 6 weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks
DRUG	Placebo	1. Cap Placebo TDS for six weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-01-10
• Last updated: 2012-10-16

Locations

1 site across 1 country: Pakistan