Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome (SBIBS)
Recruitment status was Recruiting
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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 |
- 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 ]
| 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00543478
| Contact: Lubna Kamani, FCPS, MRCP | 9221-4864659 | lubna.kamani@aku.edu |
| 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 | |
| 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 Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases |
Disease Gastrointestinal Diseases Intestinal Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 01, 2015