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AGA enrolls first patient in fecal transplant registry

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The first participant has enrolled in a large national registry designed to gather data on fecal microbiota transplantation, according to a press release issued by the American Gastroenterological Association.

The AGA is partnering with the American Gut Project and OpenBiome to administer the NIH-funded registry, which will track 4,000 patients at 75 sites for 10 years to provide data about fecal microbiota transplantation’s (FMT) effectiveness, as well as its short and long-term effects.

“What’s ahead is a significant repository of data for investigators working to advance FMT research, better information for physicians on when and how to use FMT, and reassurance for patients that we now understand the risks and benefits of this procedure,” Gary D. Wu, MD, founding chair of the AGA Center for Gut Microbiome Research and Education scientific advisory board, said in the press release. “We look forward to embarking on this comprehensive data collection project and are eager to share our findings with the public.”

The registry’s first participant–treated for multiply recurrent Clostridium difficile infection, the most common indication for FMT — will have four doctor follow-ups in the next 2 years and will provide yearly reports for up to 10 years, according to the press release.

The American Gut Project, an academic effort based at the University of California, San Diego, will build and biobank for the registry, which will contain pre- and post-FMT stool samples. Microbiota from every sample will be sequenced, and any remaining material will be frozen for future research. Information obtained through this testing could help doctors select the best donor samples for each individual patient, according to the press release.

OpenBiome — the country’s only public stool bank — will provide screening information and samples for enrolled patients who receive FMT material from OpenBiome to support the registry’s research analysis.

“This study takes aim at some of the biggest questions we have about the burgeoning field of microbiome engineering,” Carolyn A. Edelstein, MPA, executive director of OpenBiome, said in a press release. “The repository of information, especially the unprecedented longitudinal data from FMT recipients, will inform physicians, researchers and patients on the risks, benefits and most effective ways to use FMT as treatment for C. diff infections. It will also help us detect new diseases that might be treatable by changing the microbiome.” – by Alex Young

Disclosures: Edelstein is employed by OpenBiome. Wu reports he is a co-inventor on a patent on relevant concepts; has consulting agreements with Chr. Hansen, Janssen and Pfizer; and receives research funding from Takeda, Nestle, Seres Therapeutics and Intercept Pharmaceuticals.