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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 12, 2007 | ||||
| Last Updated Date | October 12, 2007 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire. [ Time Frame: 10 weeks ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome | ||||
| Official Title ICMJE | Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome | ||||
| 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? |
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| 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.
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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Irritable Bowel Syndrome | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 42 | ||||
| Estimated Completion Date | July 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Pakistan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00543478 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | SB, URC 071006MED | ||||
| Study Sponsor ICMJE | Aga Khan University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Aga Khan University | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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