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Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome (SBIBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Saccharomyces boulardii
Methyl cellulose powder (low viscosity)
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Diarrhea, Probiotics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome.
  • Age between 18- 60 years.
  • Male and female both.
  • Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years.
  • All Patients need to satisfy ROME III criteria

Exclusion Criteria:

  • Age < 18 and > 60 years
  • Pregnant and lactating females
  • Patients on laxatives or antidiarrheal drugs that could influence the motility of gut
  • Patient on antibiotics or within 2 weeks of starting protocol.
  • Not willing to participate
  • Non-compliant in run in period.
  • Patients taking Husk.
  • Diabetic patients

Sites / Locations

  • Gastroenterology outpatients clinics,Aga Khan University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.

Placebo will be given twice a day for 10 weeks

Outcomes

Primary Outcome Measures

Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence

Secondary Outcome Measures

Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.

Full Information

First Posted
October 12, 2007
Last Updated
October 12, 2007
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT00543478
Brief Title
Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome
Acronym
SBIBS
Official Title
Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology. Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?
Detailed Description
Irritable bowel syndrome (IBS) is a common functional disorder and may lead to impaired social and personal function and can diminish quality of life.While the precise pathophysiology of IBS remains to be elucidated, dysmotility and altered visceral sensory perception are currently the most popular hypothesis. There has been a suggestion that some patients with IBS may harbor bacterial overgrowth leading to low grade inflammation, immune activation, and their symptoms may be ameliorated by its eradication.Probiotics, defined as live or attenuated bacteria or micro organism that confer a significant health benefit to the host. I. Firstly, probiotic organism exert antibacterial and antiviral effects. II. Probiotics could alter the composition of the gut flora, either directly through augmentation of commensal or indirectly through a reduction in pathogen related inflammation or bacterial fermentation. Trial protocol: Phase 1: placebo BID (1 week),both arms Phase 2: Randomization by pharmacy, placebo vs. active drug (6 weeks) Phase 3: placebo BID (1 week), both arms -III. Probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces by reducing mucosal inflammation, decreasing immune mediated activation of enteric motor and sensory neurons and modifying neural traffic between the gut and central nervous system. Saccharomyces Boulardii is a probiotic yeast and its role for the treatment of IBS has not been extensively investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, Diarrhea, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo will be given twice a day for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Saccharomyces boulardii
Intervention Description
250mg, twice a day in sachets, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Methyl cellulose powder (low viscosity)
Intervention Description
twice a day sachets for 10 weeks
Primary Outcome Measure Information:
Title
Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome. Age between 18- 60 years. Male and female both. Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years. All Patients need to satisfy ROME III criteria Exclusion Criteria: Age < 18 and > 60 years Pregnant and lactating females Patients on laxatives or antidiarrheal drugs that could influence the motility of gut Patient on antibiotics or within 2 weeks of starting protocol. Not willing to participate Non-compliant in run in period. Patients taking Husk. Diabetic patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lubna Kamani, FCPS, MRCP
Phone
9221-4864659
Email
lubna.kamani@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lubna Kamani, FCPS,MRCP
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology outpatients clinics,Aga Khan University hospital
City
Karachi.
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lubna Kamani, FCPS,MRCP
Phone
9221-4864659
Email
lubna.kamani@aku.edu
First Name & Middle Initial & Last Name & Degree
Wasim Jafri, FRCP
Phone
9221-4864661
Email
wasim.jafri@aku.edu
First Name & Middle Initial & Last Name & Degree
Lubna Kamani, FCPS,MRCP

12. IPD Sharing Statement

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Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome

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