NCT06697119

Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Irritable Bowel Syndrome

Active, enrolled NA Last updated 20 November 2024

What this trial tests

NA trial testing Fecal Microbial Transplantation in Irritable Bowel Disease in 44 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 March 2023

Primary endpoint
3 July 2024

25 April 2027

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	9 March 2023
Primary completion	3 July 2024
Estimated completion	25 April 2027
Sites	1 location across South Korea

Drugs / interventions tested

• Fecal Microbial Transplantation — full drug profile →

Conditions studied

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

Sponsor

Seoul National University Hospital

Who can join

Adults 19 to 80, any sex, with Irritable Bowel Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to assess the efficacy and safety of fecal microbiota transplantation (FMT) for patients with irritable bowel syndrome (IBS). The main objectives of the study are:

To determine if FMT can significantly reduce IBS symptoms and improve patients' quality of life.

To evaluate any potential adverse effects associated with FMT in IBS patients. Researchers will compare outcomes in patients receiving FMT with a standard care protocol to gauge the effectiveness of FMT in alleviating IBS symptoms.

Participants will:

Receive FMT via endoscopic methods as per the study protocol. Attend scheduled clinic visits for assessments and symptom tracking over a 48-week period, with optional long-term follow-up for up to 3 years.

Complete regular questionnaires and microbiota assessments to monitor symptoms and gut health changes over time.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Predictors of Treatment Response to Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Pilot Study.
   Lee HK, Shin CM, Chang YH, Jo H, et al · · 2025 · cited 3× · PMID 41077748 · DOI 10.5056/jnm24183