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Saccharomyces Boulardii in Irritable Bowel Syndrome (SB-IBS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Aga Khan University.   Recruitment status was  Not yet recruiting

First Received on December 26, 2007.   No Changes Posted
Sponsor: Aga Khan University
Collaborator: Biocodex
Information provided by: Aga Khan University
ClinicalTrials.gov Identifier: NCT00589771
  Purpose

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).


Condition Intervention Phase
Diarrhea Dominant Irritable Bowel Syndrome
 Drug: Saccharomyces boulardii
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
Drug Information available for: Saccharomyces boulardii
U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: January 2008
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Capsule Saccharomyces boulardii 250 mg TDS
 Drug: Saccharomyces boulardii
Saccharomyces boulardii one capsule 250mg BD for 6 weeks
Other Name: Enflor
Placebo Comparator: B
Capsule Placebo TDS
 Drug: Placebo
Cap Placebo TDS for six weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589771

Locations
Pakistan
Aga Khan University Hospital Not yet recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Zaigham Abbas, FACG     4930051 ext 4659     zaigham@akunet.org    
Contact: Javed Yakoob, PhD     922148930051 ext 4679     yakoobjaved@hotmail.com    
Sub-Investigator: Javed Yakoob, PHD            
Sub-Investigator: Wasim Jafri, FACG            
Sponsors and Collaborators
Aga Khan University
Biocodex
Investigators
Principal Investigator: Zaigham Abbas, FACG Aga Khan University HOSPITAL
  More Information

No publications provided

Responsible Party: Zaigham Abbas, Aga Khan University
ClinicalTrials.gov Identifier: NCT00589771     History of Changes
Other Study ID Numbers: 674- MED, 2007-674MED-ERC, SB-IBS-674, SB-IBS-cytokines-674
Study First Received: December 26, 2007
Last Updated: December 26, 2007
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
IBS
Saccharomyces boulardii
probiotics
 cytokine
histology
Efficacy

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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