Real-World Evidence Suggests FMT Is Safe, Highly Effective for Treatment of Clostridioides difficile Infections

Clostridium difficile bacteria
Clostridium difficile bacteria
The FMT National Registry, established by the AGA in partnership with other organizations, provides initial results on the safety and effectiveness of FMT for the management of Clostridioides difficile infections.

Real-world evidence suggests fecal microbiota transplantation (FMT) may be considered a relatively safe and highly effective treatment option for Clostridioides difficile infections (CDIs). This evidence was described in the initial results of the FMT National Registry published in a recent edition of Gastroenterology.

The ongoing, observational FMT National Registry includes North American patients who have undergone FMT for any indication. Researchers examined deidentified data, including the FMT protocol, baseline patient characteristics, rates of CDI cure and recurrence, and short- and long-term safety outcomes. Sites participating in the FMT National Registry collected the data at baseline and at both 1 and 6 months and 1 and 2 years after the FMT procedure.

A total of 22 patients had completed follow-up at 1 month, and 123 patients completed 6-month follow-up. Approximately 66% of patients were female, and ages of participants in the overall cohort ranged between 1 and 98 years (median, 63 years).

The FMT procedures were performed for CDI in all cases. Approximately 96% of procedures relied on an unknown donor from a stool bank. The 1-month cure rate was 90%. Cure at 1 month was the result of only 1 FMT procedure in 98% of cases. Only 4% of the 112 patients with an initial cure experienced a CDI occurrence during 6-month follow-up.

Adverse events reported up to 1 month after FMT included diarrhea (30%), abdominal pain (17%), bloating (15%), constipation (10%), and nausea or vomiting (6%). Severe adverse events associated with FMT within this same time period also included diarrhea (2%) and abdominal pain (2%). Three patients (1%) were hospitalized during the month following FMT, possibly as a result of the procedure.

Irritable bowel syndrome was diagnosed in 2 patients (1%) and inflammatory bowel disease was diagnosed in 2 patients (1%) at the 6-month follow-up. 

Limitations of this study include the relatively short follow-up period, lost follow-up data for some patients, and variations in donor screening protocols across participating sites.

The researchers suggest that the evidence generated from this real-world practice registry offers FMT practitioners, in addition to the research community, an opportunity “to protect the safety of patients receiving FMT” as well as “gain tremendous new insights into the biology of the human gut microbiome.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Kelly CR, Yen EF, Grinspan AM, et al. Fecal microbiota transplantation is highly effective in real-world practice: initial results from the FMT National Registry. Gastroenterology. Published online October 1, 2020. doi:10.1053/j.gastro.2020.09.038