Clinical trial NCT00543478: Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome
Official title: Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Diarrhea
Probiotics
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2007-10-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 10 weeks
Secondary outcomes:
measure: Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Karachi.
country: Pakistan
facility: Gastroenterology outpatients clinics,Aga Khan University hospital
Study officials:
affiliation: Aga Khan University
name: Lubna Kamani, FCPS,MRCP
role: PRINCIPAL_INVESTIGATOR
References: