Effect of Probiotic Supplement on Bowel Function
Phase 2
Terminated
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Dietary Supplement: Probiotic supplement
- Registration Number
- NCT01475929
- Lead Sponsor
- Danisco
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 149
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Probiotic supplement - Probiotic high Probiotic supplement Higher dose of probiotic supplement Probiotic low Probiotic supplement Lower dose of probiotic supplement
- Primary Outcome Measures
Name Time Method Change in functional bowel symptoms 0 weeks, 6 weeks, 12 weeks Validated questionnaire
- Secondary Outcome Measures
Name Time Method Adequate relief Weekly over 3 month intervention Weekly question
Change in faecal microbiota 0 weeks, 6 weeks, 12 weeks Quantification of selected microbes and the intervention strain from faecal samples
Change in quality of life 0 weeks, 6 weeks, 12 weeks Validated questionnaire
Trial Locations
- Locations (1)
Herttoniemi Hospital
🇫🇮Helsinki, Finland