Saccharomyces Boulardii in Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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).

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

Conditions
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Diarrhea Dominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Saccharomyces boulardii
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diarrhea-predominant IBS satisfying ROME III criteria. Adults aged 18-70 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Capsule Saccharomyces boulardii 250 mg TDS for six weeks. Ispahgula husk 1 Tsf daily after dinner for six weeks. | Drug: Saccharomyces boulardii<br>* Saccharomyces boulardii one capsule 250mg TDS for 6 weeks Ispaghula husk 1 Tsf daily after dinner for six weeks<br>* Other names: Enflor;|
| Placebo Comparator: B<br>Capsule Placebo TDS for six weeks. Ispaghula husk 1 Tsf daily after dinner for six weeks | Drug: Placebo<br>* Cap Placebo TDS for six weeks Ispaghula husk 1 Tsf daily after dinner for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Saccharomyces boulardii, probiotics, cytokine, histology, Efficacy