NEW YORK (Reuters Health) – Fecal microbiota transplantation (FMT) prevents recurrent C. difficile infection whether delivered by oral capsule or by colonoscopy, according to results from a randomized noninferiority trial.
“Since the efficacy of FMT by capsules is not inferior to colonoscopy delivery, treatment of mild to moderate RCDI can become an office-based therapy,” Dr. Dina Kao from University of Alberta, Edmonton, Canada, told Reuters Health by email. “There is no obvious advantage to colonoscopy-delivered FMT, and perhaps we should move away from colonoscopy-delivered FMT in this context, unless an alternative diagnosis is suspected.”
FMT administered by colonoscopy is 90% effective for preventing recurrent C. difficile infection, but it remains unclear whether clinical efficacy differs by route of delivery.
Dr. Kao’s team from three academic centers investigated whether the same amount of donor FMT by oral capsule is noninferior to FMT delivery by colonoscopy in a randomized trial of 116 patients (mean age, 58) who each had at least three documented episodes of C. difficile infection.
According to the November 28 JAMA online report, 105 patients completed the study (53 in the capsule group, 52 in the colonoscopy group).
After receiving a single treatment, 96% of both groups were free of recurrent C. difficile infection at 12 weeks. The two patients in each group who developed recurrent infection were successfully treated with a second FMT by the original modality.
The groups did not differ in quality-of-life measures at four weeks, although more patients receiving capsules (66%) than colonoscopy (44%) rated their experience as “not at all unpleasant.”
More than three quarters of participants (79%) reported the unpleasantness to be the same as or less than anticipated, and 97% indicated they would undergo the assigned delivery method again if needed.
Minor adverse events were less common in the capsule group (5.4%) than in the colonoscopy group (12.5%), and the cost of administering FMT was much lower by capsule ($395 Canadian, $308 US) than by colonoscopy ($1,120 Canadian, $874 US).
Microbial diversity increased significantly and to a similar extent with either FMT delivery method; this diversity was maintained in both groups up to 12 weeks after FMT.
“Treating these RCDI (recurrent C. difficile infection) patients has been the most rewarding thing I have done in my entire professional career,” Dr. Kao said. “They are absolutely the most grateful patients. Again, I think this speaks to how their quality of life was so adversely affected by it.”
Dr. Preeti N. Malani, a JAMA associate editor from University of Michigan Medical School, Ann Arbor, who coauthored an accompanying editorial, told Reuters Health by email, “This study adds to the growing body of literature that suggests oral capsules are a good alternative to colonoscopy-delivered FMT.”
“In theory, oral capsules would be easier to use and potentially safer, although there are a lot of pills to swallow, which can be a barrier for some patients,” she said.
“It’s important to emphasize that there is a lot we don’t know about FMT, especially in regard to long-term health consequences,” Dr. Malani said. “Also, not every patient with recurrent CDI should have FMT. It’s important to involve clinicians with expertise in C. difficile and FMT to help determine the optimal approach for each patient.”
SOURCES: http://bit.ly/2idaeQD and http://bit.ly/2nbsoUJ
JAMA 2017.
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