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Saccharomyces Boulardii in Irritable Bowel Syndrome

NCT ID: NCT00589771

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

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).

Detailed Description

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Conditions

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Diarrhea Dominant Irritable Bowel Syndrome

Keywords

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IBS Saccharomyces boulardii probiotics cytokine histology Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

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

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type DRUG

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

B

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Saccharomyces boulardii

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Enflor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biocodex

INDUSTRY

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Zaigham Abbas

Consultant Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zaigham Abbas, FACG

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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2007-674MED-ERC

Identifier Type: -

Identifier Source: secondary_id

SB-IBS-674

Identifier Type: -

Identifier Source: secondary_id

SB-IBS-cytokines-674

Identifier Type: -

Identifier Source: secondary_id

674- MED

Identifier Type: -

Identifier Source: org_study_id