Saccharomyces Boulardii in Irritable Bowel Syndrome (SB-IBS)

October 14, 2012 updated by: Zaigham Abbas, Aga Khan University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
  1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks.
  2. Ispahgula husk 1 Tsf daily after dinner for six weeks.
Drug: Saccharomyces boulardii
  1. Saccharomyces boulardii one capsule 250mg TDS for 6 weeks
  2. Ispaghula husk 1 Tsf daily after dinner for six weeks
Other Names:
  • Enflor
Placebo Comparator: B
  1. Capsule Placebo TDS for six 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

Biocodex

Investigators

  • Principal Investigator: Zaigham Abbas, FACG, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

October 16, 2012

Last Update Submitted That Met QC Criteria

October 14, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 674- MED
  • 2007-674MED-ERC
  • SB-IBS-674
  • SB-IBS-cytokines-674

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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