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AGA launches first-ever fecal microbiota transplant registry

AGA recently launched the world’s first fecal microbiota transplant (FMT) registry. Loren Laine, MD, AGAF, will discuss the registry, which is sponsored by the National Institutes of Health (NIH), during Sunday’s AGA Committee Sponsored Symposium A Clinician’s Guide to FMT: Practical Advances and Challenges. This session is sponsored by the AGA Center for Gut Microbiome Research and Education.

“We want to get a good look at the practice of FMT in the real world,” said Dr. Laine, one of three co-principal investigators for the registry and professor of medicine at Yale University, New Haven, CT. “There are a lot of ways to do FMT and nobody knows the right ways or even what the real efficacy is in real-world settings. There are theoretical reasons to be concerned that — when you give someone a fecal transplant, you might induce disease. The long-term safety of FMT, however, has never been explored.”
Colleen Kelly, MD, another co-principal investigator for the registry, will discuss the use of FMT in the treatment of recurrent C. difficile infection.

“We are already taking care of a lot more patients with C. difficile infection and we’re going to be seeing even more with an aging population spending more time in the hospital,” said Dr. Kelly, assistant professor of medicine at Brown Alpert Medical School, Providence, RI. “Even if you don’t do FMT today, you are going to be asked to do it in the future.”

Today, FMT is primarily used to treat C. difficile infection that is refractory to standard treatment, said Dr. Laine, but noted that there is potential to use the procedure for inflammatory bowel disease and other conditions.

There are multiple routes for FMT, including colonoscopy, enema, nasointestinal tube and capsule. All may work, Dr. Kelly said, but colonoscopy appears to provide the best efficacy. Colonoscopy allows instillation of donor stool deeper into the large intestine and gives the gastroenterologist diagnostic opportunities that are missing with the other routes.

Unable to perform colonoscopy, non-gastroenterologists tend to prefer other routes. Enemas and capsules can be effective, but typically need multiple applications to match the efficacy of a single colonoscopic instillation.

“Each oral dose requires 12 to 20 capsules to give the same amount of stool that you would give by colonoscopy,” Dr. Kelly said. “That can be a daunting number of capsules to swallow at once.”

Some of the earliest articles describing FMT used nasointestinal installation. But those early successes have been followed by multiple reports of patients aspirating stool and developing pneumonia.

There are also questions surrounding the source and preparation of stool for FMT, as well as the rigor of screening that is needed for stool donors.
With more questions than answers about FMT, AGA received funding from the National Institute of Allergy and Infectious Diseases (Award Number R24AI118629) to establish the new registry and address some of those practical issues in collaboration with the Infectious Diseases Society of America, the Crohn’s & Colitis Foundation, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration were also involved in the earliest discussions regarding the registry concept and design.

The registry is intended to follow 4,000 patients for 10 years at 75 centers in North America. “The registry will provide the first accurate look at clinical practice for FMT, as well as the first long-term safety and efficacy data,” Dr. Laine said

Dr. Kelly added: “A few years ago, you could say, ‘Sorry, I don’t do FMT.’ But the onus is now on the clinician to figure out how to offer it to their patients, or at least to understand the appropriate indications for the procedure. Everyone in GI is going to have to know about FMT.”

Please refer to the DDW Mobile App or the Program section in Sunday’s DDW Daily News for additional details on this and other DDW® events.

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