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AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation (FMT)

Ninety percent of patients tracked in the AGA FMT National Registry were cured of C. difficile infection with few serious side effects.
Human microbiota samples under a microscope
Human microbiota samples under a microscope

AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of Clostridioides difficile (C. difficile) infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.

“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, Associate Professor of Medicine at Brown University in Providence, Rhode Island and co-principal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”

This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the one-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only two were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the six months after successful FMT occurring in only 4% of participants. This data includes patients with co-morbidities, such as inflammatory bowel disease and immunocompromised status, who are typically excluded from FMT clinical trials.

“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.

About the AGA FMT National Registry

Established in 2016, the FMT National Registry — funded by NIAID of the NIH (Award Number R24AI118629) and administered by the AGA Center for Gut Microbiome Research and Education — assesses short- and long-term patient outcomes associated with FMT with a goal of tracking over 4,000 patients over 10 years. As of August 2020, 449 participants have enrolled in the registry. Our registry is designed to provide long-term assessment for up to 10 years to answer the most pressing safety question regarding FMT: whether FMT increases the risk of developing other medical conditions in the years after it is performed. If you treat patients using FMT, please join this important research effort.

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