Drug intelligence / Profile preview

autologous fecal microbiota transplantation (Mayo Clinic)

Development stage
Unknown
Lead developer
Rutgers University
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Rectal
01

Overview

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.

Other names
autologous FMTauto-FMTautologous fecal microbiota transplant

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