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Safety and Efficacy of a Probiotic Supplement in IBS-D — IBIS  

Irritable Bowel Syndrome Clinical Trial

Official title:
Evaluating the Safety and Efficacy of a Probiotic on IBS Symptom Severity in Adults With Diarrhoea-predominant Irritable Bowel Syndrome

Clinical Trial Summary

This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).

Clinical Trial Description

This is a double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with IBS-D, when consumed orally in capsule form once daily for 84 days. Volunteers will be screened in order to identify up to 134 participants meeting ROME IV criteria for IBS-D. The study will involve 5 visits over a total of 105 days [visit 1: screening, commencement of run in period (-21 to -14 days), visit 2: baseline/ randomisation (day 0), visits 3 and 4: intervention period (day 28 ± 2, day 56 ± 2), visit 5: end of study (day 84± 2)]. Participants will fill in daily and weekly eDiaries, and questionnaires will be administered at study visits. Faecal samples will be collected on visits 2 and 5. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05754177
Study type Interventional
Source The Archer-Daniels-Midland Company
Contact ADM Medical Team
Phone +44 1460 243 230
Email medical@protexin.com
Status Recruiting
Phase N/A
Start date June 6, 2023
Completion date December 15, 2024
View Details
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