August 04, 2016
2 min read

AGA receives NIH funding for first national FMT registry

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The National Institute of Allergy and Infectious Diseases of the NIH has provided funding to launch the AGA Fecal Microbiota Transplantation National Registry, the first national registry to track short- and long-term outcomes in patients who have undergone the gut-microbiome based therapy.

Part of the AGA Center for Gut Microbiome Research and Education, this program will allow investigators to better understand the potential health risks associated with transferring stool from donor to recipient, which could include development of chronic conditions like irritable bowel syndrome, obesity and diabetes in the long term. Understanding of these potential safety concerns is currently limited as the clinical application of FMT has outpaced scientific study, according to an AGA press release.

Colleen R. Kelly

“The immediate goal of the FMT registry is to protect patient safety by providing a central place in which to collect patient outcomes and monitor potential issues that we may not even know about yet,” Colleen R. Kelly, MD, from the Lifespan Women’s Medicine Collaborative and Alpert Medical School of Brown University, one of the registry’s principal investigators, said in the press release. “Long term, the data we collect will be of enormous value, offering the scientific community a rich resource of information about manipulation of the gut microbiota in humans to promote health and treat disease.”

The registry — also led by Kelly’s fellow AGA Center for Gut Microbiome Research and Education scientific advisory board members Loren Laine, MD, AGAF, and Gary D. Wu, MD will prospectively enroll FMT patients throughout the U.S. and collect baseline data on donors and recipients as well as FMT methodologies and indications. Researchers will follow patients for up to 10 years for treatment effectiveness and adverse events.

Timothy C. Wang

The registry steering committee also includes members of The Crohn’s & Colitis Foundation of America, the Infectious Diseases Society of America and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

“We are in a unique position in which the responsibility to protect the safety of patients receiving FMT is combined with the opportunity to gain tremendous new insights into the biology of the human gut microbiome,” AGA President Timothy C. Wang, MD, AGAF, said in the press release. “AGA is eager to put a formal infrastructure into place for physicians and patients to report information that will standardize best practices for FMT, while offering insight into the gut microbiome and its role in human health and disease.”