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Saccharomyces Boulardii in Irritable Bowel Syndrome

NCT00589771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2012-10-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biocodex

    collaborator INDUSTRY

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Zaigham Abbas, FACG · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Pakistan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00589771 on ClinicalTrials.gov