"That probably bears repeating," commented press briefing discussant Dr. Brian E. Lacy, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. "So if somebody came to you and said, right now, what do you think are the best indications for FMT, what would your answer be?"
"Recurrent C. difficile infection or refractory C. difficile infection – people who aren’t getting better on antibiotics," Dr. Kelly replied.
"Some would say severe C. difficile infection, but that’s another place where I’d probably say there is a yellow light of caution, because in my experience, we have treated very few patients with severe C. diff infection. They don’t appear to do as well," she continued. "They are also much more complicated; they are very sick, patients in the intensive care unit with toxic megacolon. The standard of care in these patients in 2013 is a surgical colectomy."
In the study, the investigators reviewed data collected from 16 centers performing FMT for recurrent, refractory, severe, or complicated C. difficile infection.
Analyses were restricted to immunocompromised patients who underwent the procedure and had at least 12 weeks of follow-up. Overall, 92% of the patients were adults, with a mean age of 53 years (range, 20-82 years). Sixty-two percent of the patients were men.
The reason for immunocompromise was use of immunosuppressive medications for IBD in 48% of patients, receipt of a solid organ transplant in 21%, a chronic medical condition and/or use of other immunosuppressive medication in 18%, cancer or its treatment in 9%, and HIV/AIDS in 3%.
The C. difficile infection was recurrent in 54% of cases, refractory in 12%, and severe or complicated in 34%.
The large majority of the patients (78%) underwent their FMT procedure in the outpatient setting. On average, the mean follow-up was 12 months (range, 3-51 months).
The results showed that 52 patients did not have any recurrence of C. difficile infection within 12 weeks of FMT, reported Dr. Ihunnah. Nine of the patients who had a recurrence underwent a second FMT, and seven of them did not have any additional recurrences. The final cure rate was therefore 89%.
Overall, nine patients (14%) had a serious adverse event within 12 weeks of their FMT: There were seven unplanned hospitalizations (most commonly due to a flare of IBD) and two deaths (one due to worsening of preexisting pneumonia unrelated to FMT and the one due to aspiration).
Nonserious adverse events included two cases of self-limited diarrhea in which no pathogen was identified, four cases of mild abdominal discomfort, one case of minor mucosal tear, and two cases of colectomy among patients with ulcerative colitis performed more than 100 days after FMT.
Dr. Ihunnah and Dr. Kelly disclosed no relevant conflicts of interest.