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Autologous fecal microbiota transplantation (FMT) is a procedure involving the collection, processing, and re-administration of a patient's own fecal matter. In the PRAGMAT (Proteolytic Activity-Guided FMT for IBS) trial, led by Dr. Madhusudan Grover at the Mayo Clinic, this intervention is utilized as a placebo control for patients with post-infection irritable bowel syndrome (PI-IBS) who exhibit high proteolytic activity. The trial aims to compare the efficacy of a donor FMT—specifically from donors with low proteolytic activity and the presence of Alistipes putredinis—against this autologous control. The procedure involves a single administration of 50 grams of freeze-thawed stool via colonoscopy, with the primary endpoint being a significant improvement in the IBS symptom severity score at 12 weeks post-transplantation. The study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and has received investigational new drug (IND) approval from the FDA.
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