NCT05754177

Safety and Efficacy of a Probiotic Supplement in IBS-D

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: The Archer-Daniels-Midland Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Irritable Bowel Syndrome With Diarrhea
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria), administered orally by 1 capsule a day, for 84 days
OTHER	Placebo	Participants in this arm will receive an equivalent placebo for 84 days.

Timeline

• Start date: 2023-06-06
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-03-03
• Last updated: 2025-03-06

Locations

1 site across 1 country: Slovenia