Public Release: 

Largest planned fecal microbiota transplantation (FMT) study enrolls first patient

The FMT National Registry also announces collaborations with American Gut and OpenBiome

American Gastroenterological Association

Bethesda, MD (Jan. 10, 2018) -- The first participant has enrolled in the American Gastroenterological Association (AGA) Fecal Microbiota Transplantation (FMT) National Registry, which is planned to be the largest FMT study ever. The AGA FMT National Registry -- funded by the National Institutes of Health (NIH) and administered by the AGA Center for Gut Microbiome Research and Education -- will track 4,000 patients for 10 years after their FMT procedure, providing a wealth of data about the procedure's effectiveness and both short- and long-term effects of FMT.

Fecal microbiota transplant 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 Clostridium difficile (C. diff) infection, if antibiotics have not been able to get rid of the infection.

"Today is an important milestone for the AGA FMT National Registry. 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," said Gary D. Wu, MD, a principal investigator for the registry and founding chair of the AGA Center for Gut Microbiome Research and Education scientific advisory board. "We look forward to embarking on this comprehensive data collection project and are eager to share our findings with the public."

First Patient Enrolled

The first patient enrolled in the FMT National Registry received a fecal transplant through the Gastroenterology Center of Connecticut/Medical Research Center of Connecticut by Paul Feuerstadt, MD, assistant clinical professor of medicine at Yale School of Medicine, New Haven, CT. The patient being treated had experienced multiple recurrences of C. difficile infection. As part of the registry, Dr. Feuerstadt will follow up with the patient four times over the next two years and report back on the patient's health post-FMT. The patient will also provide yearly reports for up to 10 years.

How Patients Can Take Part in the FMT National Registry

AGA expects 75 sites to be included in this registry. Visit ClinicalTrials.Gov <https://clinicaltrials.gov/ct2/show/study/NCT03325855?cond=FMT+National+registry&rank=1> on a regular basis to track new sites added to the registry. Patients should reach out to their health care provider to discuss participation in the registry. Patients should first review AGA's patient information on fecal microbiota transplantation (FMT) <http://www.gastro.org/info_for_patients/clostridium-difficile-106-fmt-details>.

UC San Diego to Build FMT National Registry Biobank

AGA is collaborating with the American Gut Project -- an academic effort run by the laboratory of Rob Knight, PhD, professor and director of the Center for Microbiome Innovation at the University of California, San Diego -- to build a biobank of stool samples from participants in the FMT National Registry. American Gut will receive stool samples from registry participants before and after their FMT. The microbiota will be sequenced in each sample, and remaining material will be frozen to be made available for future research. Eventually, this information could help doctors screen and select the best donor samples for individual patients.

OpenBiome Joins as a Registry Collaborator

AGA is also collaborating with OpenBiome, a public stool bank and nonprofit research organization that provides clinicians with rigorously screened, ready-to-use stool preparations for fecal transplant procedures. As the only public stool bank in the country, OpenBiome serves as the source of stool preparations for nearly 1,000 clinical partners performing FMT across the United States. For patients enrolled in the registry who receive OpenBiome FMT material, OpenBiome will provide screening information and samples to support the registry's research analyses.

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Registry Information

The AGA FMT National Registry was initially announced in August 2016 after receiving funding from the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH (award number R24AI118629). The registry is led by principal investigators Colleen Kelly, MD, Loren Laine, MD, AGAF, and Gary D. Wu, MD. AGA thanks the Crohn's & Colitis Foundation, the Infectious Diseases Society of America, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition for their partnership in this initiative.

For questions or information on how sites can participate in this registry, please email FMTRegistry@gastro.org.

About the 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. http://www.gastro.org.

The mission of the AGA Center for Gut Microbiome Research and Education is to advance research and education on the gut microbiome with the goal of improving human health. http://www.gastro.org/microbiome.

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About American Gut

The American Gut Project is a non-profit academic research project which enables anyone on the planet to participate in exciting cutting-edge microbiome research. The project is predominantly crowd-funded and crowd-sourced, having raised over $2M USD since launch in the Fall of 2012. To date, the project has received stool from over 10,000 people, while providing infrastructure for curious individuals, academic driven subprojects, and citizen science endeavors. All of the de-identified data generated, including questionnaire responses, are released for free into the public domain. Learn more at http://americangut.org.

About OpenBiome

OpenBiome is the first public stool bank, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the microbiome's role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use stool preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with almost 1,000 healthcare institutions across all 50 states and 7 countries to deliver over 30,000 treatments for recurrent C. difficile. Its research portfolio includes 49% of all U.S. trials exploring the use of fecal transplants to treat disease. Learn more at https://www.openbiome.org/

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