- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589771
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
-
-
Sindh
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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:
- 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
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
|
Other Names:
|
Placebo Comparator: B
|
|
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
Collaborators
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
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.
Clinical Trials on Diarrhea Dominant Irritable Bowel Syndrome
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-
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-
Astellas Pharma IncCompletedDiarrhea-predominant Irritable Bowel SyndromeJapan
-
Ludwig-Maximilians - University of MunichCompletedDiarrhea- Irritable Bowel SyndromeGermany
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