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Now, the American Gastroenterological Association (AGA) released the first results in the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real world study about the effectiveness and safety of FMT. Published in Gastroenterology, the registry reported that FMT resulted in a treatment of Clostridioides difficile (C. difficile) infection in 90% of individuals across 20 North American FMT clinic websites.
While the value of fecal microbiota transplantation for treating recurrent C. difficile disease is clear from research studies, the potential long-term effects of altering a patient’s gut microbiota aren’t fully known. Releasing the initial outcomes of the AGA FMT National Registry is a significant step toward understanding the real risk and benefits of microbiota therapeutics at a real-world setting.”
Dr. Colleen R. Kelly, Associate Professor of Medicine at Brown University in Providence, Rhode Island and co-principal investigator of the AGA FMT National Registry
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This new report details effectiveness and safety outcomes from the initial 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants obtained FMT with 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 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of these requiring just a single FMT. Infections were reported in 11 participants, but only two were believed to be possibly associated with the procedure.
FMT response was deemed durable, with recurrence of C. difficile infection in the six months after successful FMT happening 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 first results show a high success rate of FMT from the real-world setting. We’ll continue to monitor these patients for 10 years to evaluate long-term security, which will be critical to determining the entire safety profile of FMT,” added Dr. Kelly.
What is fecal microbiota transplantation?
Fecal microbiota transplant, or FMT, is a medical procedure where the stool from a wholesome person is prepared and then enter the intestine of a sick patient. FMT is most frequently used to treat Clostridioides difficile infection, if antibiotics have not been able to get rid of the infection. Recurrent C. difficile disease is common and increasing within the U.S.. It is associated with significant morbidity and mortality as well as frequent failure of standard medical treatments, making FMT a potentially life-saving procedure. Learn more in the AGA GI Patient Center.
American Gastroenterological Association