NCT05461833

FMT for Post-infectious IBS

Completed NA Last updated 18 July 2022

What this trial tests

NA trial testing Fecal transplantation in Irritable Bowel Syndrome in 59 participants. Completed in 15 January 2022.

Timeline

1 September 2020

Primary endpoint
31 December 2021

15 January 2022

Quick facts

Lead sponsor	Bogomolets National Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	1 September 2020
Primary completion	31 December 2021
Estimated completion	15 January 2022
Sites	2 locations across Ukraine

Drugs / interventions tested

• Fecal transplantation — full drug profile →
• OTILONII BROMIDUM — full drug profile →
• multi-strain probiotic

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Bogomolets National Medical University

Who can join

Adults 18 to 65, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fecal microbiota transplantation in patients with post-infectious irritable bowel syndrome: A randomized, clinical trial.
   Tkach S, Dorofeyev A, Kuzenko I, Sulaieva O, et al · · 2022 · cited 8× · PMID 36341232 · DOI 10.3389/fmed.2022.994911
2. Antimicrobial Resistance: The Answers.
   Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559