Safety and Efficacy of a Probiotic Supplement in IBS-D

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT05754177
• Lead Sponsor: The Archer-Daniels-Midland Company

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-03
• Study Start: 2023-06-06
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Arm receiving investigation product (probiotic)
Placebo	Placebo	Arm receiving placebo

Primary Outcome Measures

Name	Time	Method
Change in total irritable bowel syndrome symptom severity score (IBS-SSS)	Day 0, Day 28, Day 58 and Day 84	Change in IBS-SSS totals score (max 500 points) from baseline to day 28, day 58 and day 84, where higher scores mean worse outcomes

Secondary Outcome Measures

Name	Time	Method
Use of Rescue Medication	Day 0, Day 84	Comparison in total cumulative use of rescue medications between the two study arms at study end (day 84)
Percentage of population achieving a normal stool consistency	Day 0, Day 28, Day 58 and Day 84	Percentage of the population achieving normal stool consistency, defined as over 75% of total bowel movements classified as stool form type 3, 4, and 5 on Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage at baseline compared to weekly percentage at day 28, 58 and 84.
Percentage of population without diarrhea	Weekly	Percentage of the population where less than 25% of bowel movements are diarrhea, defined as stool form type 6 or 7 on the Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage calculated throughout study and compared to baseline weekly percentage.
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score	Day 0, Day 28, Day 58 and Day 84	Change in quality of life, assessed by change in the IBS-QOL total score (max 100 points) between baseline and day 28, day 58 and day 84, where higher scores mean better quality of life
Change in State-Trait Anxiety Inventory for Adults (STAI-AD) score	Day 0, Day 28, Day 58 and Day 84	Mental health as assessed by change in STAI-AD S-anxiety subscale score (max: 80), between baseline and day 28, 58 and 84, where higher scores mean more severe anxiety symptoms
Gut microbiome compositional changes	Day 0, Day 84	Change in gut microbiome composition, as assessed by shotgun sequencing of faecal samples, between baseline and study end (day 84)

Trial Locations

Locations (1)

Vizera; 🇸🇮 Ljubljana, Slovenia