NCT05776914

Fecal Microbiota Transplantation for IBS

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Madhusudan (Madhu) Grover, MBBS · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome
• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Donor Fecal Microbiota Transplantation	Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
BIOLOGICAL	Autologous Fecal Microbiota Transplantation	Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Timeline

• Start date: 2024-04-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-03-20
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study