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
  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 3

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:


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 ]

Enrollment: 72
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
  1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks.
  2. Ispahgula husk 1 Tsf daily after dinner for six weeks.
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
Placebo Comparator: B
  1. Capsule Placebo TDS for six weeks.
  2. Ispaghula husk 1 Tsf daily after dinner for six weeks
Drug: Placebo
  1. Cap Placebo TDS for six weeks
  2. Ispaghula husk 1 Tsf daily after dinner 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589771

Locations
Pakistan
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
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, Consultant Gastroenterologist, 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: October 14, 2012
Health Authority: Pakistan: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014