Saccharomyces Boulardii in Irritable Bowel Syndrome

Phase 3

Completed

• Conditions: Diarrhea Dominant Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Saccharomyces boulardii

• Registration Number: NCT00589771
• Lead Sponsor: Aga Khan University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-10
• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-14
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Diarrhea-predominant IBS satisfying ROME III criteria.
2. Adults aged 18-70

Exclusion Criteria

1. Pregnant and lactating females
2. Inflammatory bowel disease and other systemic disease
3. Patients on anti-diarrheal and antibiotics drugs
4. Patients with any ongoing infection
5. Not willing to participate
6. Allergy to any of Saccharomyces boulardii components
7. Central venous catheter carriers
8. Other probiotics e.g., Lactobacillus and Bifidobacterium

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	1. Capsule Placebo TDS for six weeks. 2. Ispaghula husk 1 Tsf daily after dinner for six weeks
A	Saccharomyces boulardii	1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks. 2. Ispahgula husk 1 Tsf daily after dinner for six weeks.

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features	6 weeks

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug	6 weeks

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan