RecruitingPhase 2NCT05776914

Fecal Microbiota Transplantation for IBS

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

Sponsor

Madhusudan (Madhu) Grover, MBBS

Enrollment

43 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Diarrhea Irritable Bowel Syndrome

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Autologous Fecal Microbiota Transplantation and a biological treatment called Donor Fecal Microbiota Transplantation for people with diarrhea and irritable bowel syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDonor Fecal Microbiota Transplantation

Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool

BIOLOGICALAutologous Fecal Microbiota Transplantation

Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Locations(1)

Mayo Clinic in Minnesota

Rochester, Minnesota, United States

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NCT05776914

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