The AGA FMT National Registry is collaborating with OpenBiome and the University of Minnesota’s Microbiota Therapeutics Program to continue providing access to FMT for U.S. hospitals caring for patients with recurrent C. difficile infection. Through this new collaboration, OpenBiome will distribute preparations of intestinal microbiota manufactured by the University of Minnesota under the oversight of AGA member Alexander Khoruts, MD, and colleagues.
A key pillar of this new collaboration is a commitment to gather clinical outcomes data to inform patient care. All physicians using preparations from the University of Minnesota will be asked to collect short-term safety and patient outcomes and enter those data into AGA’s FMT National Registry. Our NIH-funded registry aims to systematically track the health of FMT recipients to better understand the risks and benefits of microbiota therapeutics.
OpenBiome expects to begin shipping FMT preparations manufactured by the University of Minnesota under Good Manufacturing Practice to its clinical network in the second half of 2022. This material will supplement OpenBiome’s ongoing service to physicians and maintain patient access to FMT. Sites participating in the AGA FMT National Registry who are not part of OpenBiome’s network may contact the stool bank to access FMT treatments for their patients.
Microbiota preparations from the University of Minnesota will be available in capsules for oral delivery of freeze-dried microbiota or in liquid formulations for lower intestinal delivery via colonoscopy, sigmoidoscopy or enema.