AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation
About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.
AGA has 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 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 Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal 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 risks 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 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD 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.
AGA raises concerns about recent executive order
We are speaking out to ensure a brighter and more equitable future.
AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.
We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.
As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.
By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.
AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.
Our commitment to this issue is manifest in the AGA Equity Project.
