Bethesda, MD (Oct. 1, 2020) — Today, the American Gastroenterological Association (AGA) 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 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. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risk 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 1-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.
WHAT IS FECAL MICROBIOTA TRANSPLANTATION?
Fecal microbiota transplant, or FMT, is a medical procedure in which the stool from a healthy person is prepared and then put into the intestine of a sick patient. FMT is most commonly used to treat Clostridioides difficile infection, if antibiotics have not been able to get rid of the infection. Recurrent C. difficile infection is common and increasing within the U.S. It is associated with significant morbidity and mortality and frequent failure of standard medical treatments, making FMT a potentially life-saving procedure. Learn more in the AGA GI Patient Center.
ABOUT THE AGA FMT NATIONAL REGISTRY
Established in 2016, the FMT National Registry – funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (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. Read more about the AGA Fecal Microbiota Transplantation National Registry. ClinicalTrials.gov Identifier: NCT03325855
GUT MICROBIOME EXPERTS
AGA has recruited leading experts in the gut microbiome and digestive health to serve as the scientific advisory board for the AGA Center for Gut Microbiome Research & Education. Email [email protected] to speak with our experts about FMT or other microbiome topics.
ABOUT AGA INSTITUTE
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization.www.gastro.org.
ABOUT GASTROENTEROLOGY
Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, Current Awareness in Biological Sciences, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit www.gastrojournal.org.
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