Saccharomyces Boulardii in Irritable Bowel Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

December 26, 2007

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Saccharomyces Boulardii in Irritable Bowel Syndrome

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diarrhea Dominant Irritable Bowel Syndrome

Intervention ^ICMJE

Drug: Saccharomyces boulardii
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Capsule Saccharomyces boulardii 250 mg TDS
Placebo Comparator: Capsule Placebo TDS

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Pakistan

Administrative Information

NCT ID ^ICMJE

NCT00589771

Responsible Party

Zaigham Abbas, Aga Khan University

Study ID Numbers ^ICMJE

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

Study Sponsor ^ICMJE

Aga Khan University

Collaborators ^ICMJE

Biocodex

Investigators ^ICMJE

Principal Investigator:

Zaigham Abbas, FACG

Aga Khan University HOSPITAL

Information Provided By

Aga Khan University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP