Who is sponsoring NCT05776914?

NCT05776914 is sponsored by Madhusudan (Madhu) Grover, MBBS.

What condition does NCT05776914 study?

NCT05776914 studies Irritable Bowel Syndrome, Diarrhea.

What drugs are being tested in NCT05776914?

Interventions: Donor Fecal Microbiota Transplantation, Autologous Fecal Microbiota Transplantation.

What is the status of NCT05776914?

NCT05776914 is currently RECRUITING.

Last reviewed 2026-05-06 · How we verify

Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)

NCT05776914 Phase 2 RECRUITING

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

Details

Lead sponsor	Madhusudan (Madhu) Grover, MBBS
Phase	Phase 2
Status	RECRUITING
Enrolment	43
Start date	2024-04-15
Completion	2027-06-26

Conditions

Irritable Bowel Syndrome
Diarrhea

Interventions

Donor Fecal Microbiota Transplantation
Autologous Fecal Microbiota Transplantation

Primary outcomes

Percentage of responders — 12 weeks
Number of subjects receiving the donor fecal microbiota transplantation identified as a responder defined as a decrease of ≥50 points in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from baseline. The Irritable Bowel Syndrome Symptom Severity Score scale has a possible range of scores from 0-500. Mild cases are classified as a score of 75-175, moderate cases are classified as a score of 175-300, and severe cases are classified as a score of \>300.

Countries

United States