Irritable Bowel Syndrome
Conditions
Keywords
irritable bowel syndrome, probiotic
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.
Interventions
DIETARY_SUPPLEMENTProbiotic supplement
A single strain probiotic supplement given at two doses
Sponsors
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional bowel symptoms | 0 weeks, 6 weeks, 12 weeks | Validated questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | 0 weeks, 6 weeks, 12 weeks | Validated questionnaire |
| 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 |
Countries
Finland
Outcome results
None listed