NCT01475929
Terminated
Phase 2
Effect of Probiotic Supplement on Bowel Function
Danisco1 site in 1 country149 target enrollmentJune 2011
ConditionsIrritable Bowel Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Danisco
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Change in functional bowel symptoms
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.
Detailed Description
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.
Exclusion Criteria
- •Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.
Outcomes
Primary Outcomes
Change in functional bowel symptoms
Time Frame: 0 weeks, 6 weeks, 12 weeks
Validated questionnaire
Secondary Outcomes
- Adequate relief(Weekly over 3 month intervention)
- Change in faecal microbiota(0 weeks, 6 weeks, 12 weeks)
- Change in quality of life(0 weeks, 6 weeks, 12 weeks)
Study Sites (1)
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