Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome (SBIBS)
|ClinicalTrials.gov Identifier: NCT00543478|
Recruitment Status : Unknown
Verified October 2007 by Aga Khan University.
Recruitment status was: Recruiting
First Posted : October 15, 2007
Last Update Posted : October 15, 2007
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 or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Saccharomyces boulardii Drug: Methyl cellulose powder (low viscosity)||Phase 4|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome|
|Study Start Date :||October 2007|
|Estimated Study Completion Date :||July 2008|
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
- 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 ]
- Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire. [ Time Frame: 10 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543478
|Contact: Lubna Kamani, FCPS, MRCPfirstname.lastname@example.org|
|Gastroenterology outpatients clinics,Aga Khan University hospital||Recruiting|
|Karachi., Pakistan, 74800|
|Contact: Lubna Kamani, FCPS,MRCP 9221-4864659 email@example.com|
|Contact: Wasim Jafri, FRCP 9221-4864661 firstname.lastname@example.org|
|Principal Investigator: Lubna Kamani, FCPS,MRCP|
|Principal Investigator:||Lubna Kamani, FCPS,MRCP||Aga Khan University Hospital|