Microbiome Resource Center

Microbiome Resource Center

Disclosures: The authors report no relevant financial disclosures.
January 20, 2021
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FMT appears safe long term for recurrent C. diff

Disclosures: The authors report no relevant financial disclosures.
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Fecal microbiota transplantation appeared safe with low risk for transmission of infection in patients with recurrent Clostridioides difficile infection, according to study results.

“With the expanding use of FMT in clinical practice, there are legitimate concerns about the short- and long-term safety of FMT,” Sahil Khanna, MBBS, MS, from the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minnesota, and colleagues wrote. “Recently, the FDA issued safety alerts following reports of serious adverse events due to transmission of enteric pathogens.

“These amongst other safety reports highlight the need for robust safety data for FMT.”

Researchers explored the short- and long-term safety of FMT in a prospective, survey-based study comprising 609 patients who underwent FMT for recurrent CDI. They contacted patients at 1 week, 6 months, 1 year (short-term) and at least 2 years (long-term) after FMT and recorded symptoms and new diagnoses at each time point.

The median age of the study’s patients was 56 years, most were women (64.8%) and 22.8% had inflammatory bowel disease.

At short-term follow up, more than 60% of patients had diarrhea and less than 33% had constipation, and at 1 year, 9.5% reported additional episodes of CDI.

Investigators wrote that the diarrhea lasted for less than a week in most patients and ultimately resolved in more than half. Additionally, they found that IBD, multiple FMTs and dialysis-dependent kidney disease were risk factors for diarrhea. The risk for constipation was higher among women and lower among patients with IBD.

During long-term follow up (median 3.7 years; n = 447), researchers found 73 new diagnoses, 11.8% of which were new infections, and none were related to FMT. The other most common new diagnoses were gastrointestinal (13%) and weight gain (10%).

“FMT appears safe and effective, both in the short term and long term,” Khanna and colleagues wrote. “Several new medical conditions were reported post-FMT, in particular, weight gain and IBS. These should be explored further in future prospective studies. The risk of transmission of infections appears to be low.”