Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome (SBIBS)

Study Description

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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?

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: Saccharomyces boulardii; Drug: Methyl cellulose powder (low viscosity)	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome
Study Start Date :	October 2007
Estimated Study Completion Date :	July 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00543478 History of Changes
Other Study ID Numbers:	SB; URC 071006MED
First Posted:	October 15, 2007
Last Update Posted:	October 15, 2007
Last Verified:	October 2007

Keywords provided by Aga Khan University:

Irritable bowel syndrome; Diarrhea; Probiotics

Additional relevant MeSH terms:

Syndrome; Diarrhea; Irritable Bowel Syndrome; Disease; Pathologic Processes; Signs and Symptoms, Digestive	Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases