Irritable Bowel Syndrome Clinical Trial
Official title:
Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial
1. To assess the effect of multistrain probiotics on abdominal pain using a validated
symptom severity score in IBS patients.
2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for
IBS in a tertiary referral centre
Background: Accumulating evidence supports the view that an imbalance of gut bacteria
contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers
of pathogenic bacteria and help alleviate symptoms.
Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic
diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic
(Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or
placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary
outcome measure.
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