Real-world FMT seen as highly effective for C. diff treatment
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Results from a real-word study showed fecal microbiota transplantation for Clostridioides difficile infection was highly effective, with little serious adverse events related to the procedure, according to data from Digestive Disease Week.
These were initial results from the American Gastroenterological Association FMT National Registry.
“We’re looking forward to continue to collect data on these patients and the additional patients who have been enrolled,” Colleen R. Kelly, MD, FACG, a gastroenterologist in the Center for Women’s Gastrointestinal Medicine at the Women’s Medicine Collaborative and assistant professor of medicine at The Warren Alpert Medical School of Brown University, said during her virtual presentation. “Since this analysis, we’ve had several hundred more patients enrolled.”
Kelly and colleagues prospectively identified 259 patients from 22 sites, of whom 222 completed 30-day follow-up after FMT for treatment of C. diff. and 152 patients who completed a 6-month follow-up. Investigators entered data into an online database that included FMT protocol, baseline characteristics and treatment indications, CDI cure at 30 days, and subsequent CDI recurrence, as well as short-term and long-term safety outcomes. All FMTs were performed for CDI, with a mean of 3.5 episodes of CDI before FMT. Additionally, 44 patients had underlying inflammatory bowel disease.
Results showed, after 30 days, a cure in 225 patients and required only 1 FMT in 223 patients. Three patients had endoscopy-related complications including one perforation and two bleeding episodes. Severe symptoms at 1 month included diarrhea (2%) and abdominal pain (2%); five patients (2%) had hospitalization considered by the investigators to be related or possibly related to FMT.
“Infections are also very rare in the 30-day time point, 95% of people had no other subsequent infection in the short-term after FMT,” she said. “Which again speaks with what we believe on the safety of the procedure in that infections transmissible by FMT appear to be quite rare. However, in the ensuing months, most were felt not related to FMT but there were two that investigators could not exclude FMT as playing a role.”
Researchers followed 133 patients with 30-day cure followed to 6 months, of whom seven had CDI recurrence at 6 months post-FMT. Seven non-CDI infections occurred between 1 and 6 months post-FMT, four patients had a new diagnosis of irritable bowel syndrome and two patients had ulcerative colitis. Investigators noted there were four deaths unrelated to FMT. – by Monica Jaramillo
Reference: Kelly CR, et al. Abstract 37. Presented at: Digestive Disease Week; May 2-5, 2020; Chicago (meeting canceled).
Disclosure: Kelly reports she is a site investigator for a clinical trial by and receives support from Finch Therapeutics.