Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome - Full Text View

Sponsor:	Aga Khan University
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00543478

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Bowel Movement Diarrhea

Drug Information available for: Cellulose sodium phosphate Saccharomyces boulardii Cellulose Methylcellulose Phosphocellulose

U.S. FDA Resources

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
1: Active Comparator Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.	Drug: Saccharomyces boulardii 250mg, twice a day in sachets, for 8 weeks
2: Placebo Comparator 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

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

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

Keywords provided by Aga Khan University:

Irritable bowel syndrome
Diarrhea
Probiotics

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Syndrome
Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on November 09, 2009