Saccharomyces Boulardii in Irritable Bowel Syndrome

NCT00589771 | Completed Phase 3 DMC

• 4 other identifiers: 674- MED2007-674MED-ERCSB-IBS-674SB-IBS-cytokines-674
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diarrhea Dominant Irritable Bowel Syndrome

Keywords

IBS; Saccharomyces boulardii; probiotics; cytokine; histology; Efficacy

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features

  6 weeks

Secondary Outcomes (1)

• Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug

  6 weeks

Study Arms (2)

A

EXPERIMENTAL

1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks. 2. Ispahgula husk 1 Tsf daily after dinner for six weeks.

Drug: Saccharomyces boulardii

B

PLACEBO COMPARATOR

1. Capsule Placebo TDS for six weeks. 2. Ispaghula husk 1 Tsf daily after dinner for six weeks

Drug: Placebo

Interventions

Saccharomyces boulardii DRUG

1. Saccharomyces boulardii one capsule 250mg TDS for 6 weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks

Also known as: Enflor

A

Placebo DRUG

1. Cap Placebo TDS for six weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diarrhea-predominant IBS satisfying ROME III criteria.
• Adults aged 18-70

You may not qualify if:

• Pregnant and lactating females
• Inflammatory bowel disease and other systemic disease
• Patients on anti-diarrheal and antibiotics drugs
• Patients with any ongoing infection
• Not willing to participate
• Allergy to any of Saccharomyces boulardii components
• Central venous catheter carriers
• Other probiotics e.g., Lactobacillus and Bifidobacterium

Sponsors & Collaborators

• Aga Khan University: lead
• Biocodex: collaborator

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Study Officials

• Zaigham Abbas, FACG

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 16, 2012

Record last verified: 2012-10

Locations

PA (1)