Saccharomyces Boulardii in Irritable Bowel Syndrome (SB-IBS)

Aga Khan University

Status and phase: Completed; Phase 3

Conditions: Diarrhea Dominant Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Saccharomyces boulardii

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00589771

674- MED

2007-674MED-ERC

SB-IBS-cytokines-674

SB-IBS-674

Details and patient eligibility

About

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).

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

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

Treatment:

Drug: Saccharomyces boulardii

B

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo