NCT03251625

Multi-strain Probiotic in the Management of IBS-D

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Probiotic Formula Capsule

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2017-08-16
• Last updated: 2018-02-05