Saccharomyces Boulardii in Irritable Bowel Syndrome (SB-IBS)

This study has been completed.

Sponsor:

Collaborator:

Biocodex

Information provided by (Responsible Party):

Zaigham Abbas, Aga Khan University

ClinicalTrials.gov Identifier:

NCT00589771

First received: December 26, 2007

Last updated: October 14, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

October 14, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

December 2011 (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

Complete list of historical versions of study NCT00589771 on ClinicalTrials.gov Archive Site

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Diarrhea Dominant Irritable Bowel Syndrome

Intervention ^ICMJE

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 Name: Enflor
Drug: Placebo
1. Cap Placebo TDS for six weeks
2. Ispaghula husk 1 Tsf daily after dinner for six weeks

Study Arm (s)

Experimental: A
1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks.
2. Ispahgula husk 1 Tsf daily after dinner for six weeks.
Intervention: Drug: Saccharomyces boulardii
Placebo Comparator: B
1. Capsule Placebo TDS for six weeks.
2. Ispaghula husk 1 Tsf daily after dinner for six weeks
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2011 (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

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Pakistan

Administrative Information

NCT Number ^ICMJE

NCT00589771

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Yes

Responsible Party

Zaigham Abbas, Aga Khan University

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

October 2012

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

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