Saccharomyces Boulardii in Irritable Bowel Syndrome

Last updated: October 14, 2012
Sponsor: Aga Khan University
Overall Status: Completed

Phase

3

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT00589771
674- MED
2007-674MED-ERC
SB-IBS-674
SB-IBS-cytokines-674
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diarrhea-predominant IBS satisfying ROME III criteria.

  2. Adults aged 18-70

Exclusion

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

Study Design

Total Participants: 72
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2011

Connect with a study center

  • Aga Khan University Hospital

    Karachi, Sindh 74800
    Pakistan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.