Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome

NCT ID: NCT00543478

Last Updated: 2007-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-07-31

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?

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; Diarrhea; Probiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Saccharomyces boulardii

Intervention Type: DRUG

250mg, twice a day in sachets, for 8 weeks

2

Placebo will be given twice a day for 10 weeks

Group Type: PLACEBO_COMPARATOR

Methyl cellulose powder (low viscosity)

Intervention Type: DRUG

twice a day sachets for 10 weeks

Interventions

Saccharomyces boulardii

250mg, twice a day in sachets, for 8 weeks

Intervention Type: DRUG

Methyl cellulose powder (low viscosity)

twice a day sachets for 10 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Principal Investigators

Lubna Kamani, FCPS,MRCP

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Gastroenterology outpatients clinics,Aga Khan University hospital

Karachi, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Lubna Kamani, FCPS, MRCP

Role: CONTACT

Phone: 9221-4864659

Email: lubna.kamani@aku.edu

Facility Contacts

Lubna Kamani, FCPS,MRCP

Role: primary

Wasim Jafri, FRCP

Role: backup

Other Identifiers

URC 071006MED

Identifier Type: -

Identifier Source: secondary_id

SB

Identifier Type: -

Identifier Source: org_study_id