Saccharomyces Boulardii in Irritable Bowel Syndrome
Information source: Aga Khan University
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diarrhea Dominant Irritable Bowel Syndrome
Intervention: Saccharomyces boulardii (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Aga Khan University Official(s) and/or principal investigator(s):
Zaigham Abbas, FACG, Principal Investigator, Affiliation: Aga Khan University HOSPITAL
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).
Clinical Details
Official title: Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features
Secondary outcome: Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Aga Khan University Hospital, Karachi, Sindh 74800, Pakistan; Not yet recruiting
Zaigham Abbas, FACG, Phone: 4930051, Ext: 4659, Email: zaigham@akunet.org
Javed Yakoob, PhD, Phone: 922148930051, Ext: 4679, Email: yakoobjaved@hotmail.com
Javed Yakoob, PHD, Sub-Investigator
Wasim Jafri, FACG, Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: September 2008
Last updated: December 26, 2007
|
