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Saccharomyces Boulardii in Irritable Bowel Syndrome (SB-IBS)

Primary Purpose

Diarrhea Dominant Irritable Bowel Syndrome

Status

Completed

Phase

Phase 3

Locations

Pakistan

Study Type

Interventional

Intervention

Saccharomyces boulardii

Placebo

About this trial

This is an interventional treatment trial for Diarrhea Dominant Irritable Bowel Syndrome focused on measuring IBS, Saccharomyces boulardii, probiotics, cytokine, histology, Efficacy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00589771

First Posted

December 26, 2007

Last Updated

October 14, 2012

Sponsor

Aga Khan University

Collaborators

Biocodex

1. Study Identification

Unique Protocol Identification Number

NCT00589771

Brief Title

Saccharomyces Boulardii in Irritable Bowel Syndrome

Acronym

SB-IBS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aga Khan University

Collaborators

Biocodex

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea Dominant Irritable Bowel Syndrome

Keywords

IBS, Saccharomyces boulardii, probiotics, cytokine, histology, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Saccharomyces boulardii

Other Intervention Name(s)

Enflor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zaigham Abbas, FACG

Organizational Affiliation

Aga Khan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aga Khan University Hospital

City

Karachi

State/Province

Sindh

ZIP/Postal Code

74800

Country

Pakistan

12. IPD Sharing Statement

Learn more about this trial

Saccharomyces Boulardii in Irritable Bowel Syndrome

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