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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
391
Higher dose of probiotic supplement
Lower dose of probiotic supplement
Placebo
Mehiläinen Töölö
Helsinki, Helsinki, Finland
Mehiläinen Turku
Turku, Turku, Finland
Change in functional bowel symptoms
Validated questionnaire
Time frame: 0 weeks, 4 weeks, 12 weeks
Change in quality of life
Validated questionnaire
Time frame: 0 weeks, 4 weeks, 12 weeks
Change in anxiety and depression
Validated questionnaire
Time frame: 0 weeks, 4 weeks and 12 weeks
Adequate relief
Weekly question
Time frame: Weekly over 3 month intervention
Change in faecal microbiota
Detection and quantification of microbes from faecal samples
Time frame: 0 weeks, 4 weeks, 12 weeks
Safety of investigational product
Recording of adverse events and serious adverse events
Time frame: Throughout the intervention phase
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