Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome (SBIBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00543478
First received: October 12, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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?


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Saccharomyces boulardii
Drug: Methyl cellulose powder (low viscosity)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

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 [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire. [ Time Frame: 10 weeks ]

Estimated Enrollment: 42
Study Start Date: October 2007
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
Active Comparator: 1
Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.
Drug: Saccharomyces boulardii
250mg, twice a day in sachets, for 8 weeks
Placebo Comparator: 2
Placebo will be given twice a day for 10 weeks
Drug: Methyl cellulose powder (low viscosity)
twice a day sachets for 10 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543478

Contacts
Contact: Lubna Kamani, FCPS, MRCP 9221-4864659 lubna.kamani@aku.edu

Locations
Pakistan
Gastroenterology outpatients clinics,Aga Khan University hospital Recruiting
Karachi., Pakistan, 74800
Contact: Lubna Kamani, FCPS,MRCP    9221-4864659    lubna.kamani@aku.edu   
Contact: Wasim Jafri, FRCP    9221-4864661    wasim.jafri@aku.edu   
Principal Investigator: Lubna Kamani, FCPS,MRCP         
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Lubna Kamani, FCPS,MRCP Aga Khan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543478     History of Changes
Other Study ID Numbers: SB, URC 071006MED
Study First Received: October 12, 2007
Last Updated: October 12, 2007
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Irritable bowel syndrome
Diarrhea
Probiotics

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Diarrhea
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014