Irritable Bowel Syndrome
Conditions
Keywords
irritable bowel syndrome, probiotic, pain, bloating, diarrhoea, constipation
Brief summary
The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).
Detailed description
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.
Interventions
DIETARY_SUPPLEMENTProbiotic (Active high)
Higher dose of probiotic supplement
DIETARY_SUPPLEMENTProbiotic (Active low)
Lower dose of probiotic supplement
DIETARY_SUPPLEMENTPlacebo
Placebo
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional bowel symptoms | 0 weeks, 4 weeks, 12 weeks | Validated questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | 0 weeks, 4 weeks, 12 weeks | Validated questionnaire |
| Change in anxiety and depression | 0 weeks, 4 weeks and 12 weeks | Validated questionnaire |
| Adequate relief | Weekly over 3 month intervention | Weekly question |
| Change in faecal microbiota | 0 weeks, 4 weeks, 12 weeks | Detection and quantification of microbes from faecal samples |
| Safety of investigational product | Throughout the intervention phase | Recording of adverse events and serious adverse events |
Countries
Finland
Outcome results
None listed