Saccharomyces Boulardii in Irritable Bowel Syndrome

Diarrhea Dominant Irritable Bowel Syndrome Clinical Trial

— SB-IBS  

Official title:

Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589771
• Other study ID #: 674- MED
• Secondary ID: 2007-674MED-ERCS
• Status: Completed
• Phase: Phase 3
• First received: December 26, 2007
• Last updated: October 14, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Dominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Saccharomyces boulardii
Saccharomyces boulardii one capsule 250mg TDS for 6 weeks Ispaghula husk 1 Tsf daily after dinner for six weeks
• Placebo
Cap Placebo TDS for six weeks Ispaghula husk 1 Tsf daily after dinner for six weeks

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Biocodex

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features		6 weeks	Yes
Secondary	Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug		6 weeks	Yes