Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Madhusudan (Madhu) Grover, MBBS
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
- Age range
- 18–70 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * IBS defined by Rome IV criteria * Non IBS-C * Moderate to severe symptoms defined by IBS-SSS≥175 * Able to safely undergo and consent to colonoscopy Exclusion Criteria * Immune deficiency or treatment with immunosuppressive medications * Severe bowel or medical disease precluding administration of bowel prep * Severe bowel or medical disease precluding colonoscopy with conscious sedation * Active cancer * Pregnant or lactating * Abdominal surgery (exception of splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, lipo…
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
Location
- Mayo Clinic in MinnesotaRochester, Minnesota