Clinical Trials Logo
  1. Home
  2. Irritable Bowel Syndrome
  3. NCT05754177

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
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT03318614 - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster Phase 2/Phase 3
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A