Large report highlights safety, effectiveness of fecal microbiota transplantation

Fecal microbiota transplantation (FMT) led to a cure of Clostridioides difficile (C. difficile) infection in 90 percent of patients across 20 North American FMT practice sites with few serious side effects reported, according to a new large-scale study from the American Gastroenterological Association published in the journal Gastroenterology.

The results are the first from the from the NIH-funded Fecal Microbiota Transplantation National Registry. The 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.

"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," said Colleen Kelly, MD, FACG, co-principal investigator and associate professor of medicine at Brown University, in a statement. "Releasing the initial results…is an important step toward understanding the true risk and benefits of microbiota therapeutics in a real-world setting."

Of the 222 participants who returned for the one-month follow-up, 200 participants (90 percent) 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 percent 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, the researchers said.

"These initial results show a high success rate of FMT in the real-world setting,” said Kelly. “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.”