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Fecal infusion effective for recurrent C. difficile infection

Clinical Question:
Is the infusion of donor feces a safe and effective treatment for recurrent Clostridium difficile infection?

Bottom Line:
The infusion of donor feces is a highly effective therapy for patients with recurrent Clostridium difficile infection. (LOE = 1b)

Reference:
van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent clostridium difficile. N Engl J Med 2013;368(5):407-415.  [PMID:23323867]

Study Design:
Randomized controlled trial (nonblinded)

Funding:
Government

Allocation:
Concealed

Setting:
Inpatient (any location)

Synopsis:
The recurrence of C. difficile infection is relatively common, and the effectiveness of antibiotic therapy appears to wane with subsequent recurrences. These authors identified 41 patients with at least one relapse, more than half of whom had failed a lengthy course of vancomycin. Patients had a mean of 3 recurrences; those who were immunocompromised or critically ill were excluded. The authors randomized the participants to 1 of 3 treatment arms: (1) oral vancomycin 500 mg 4 times per day for 14 days, (2) oral vancomycin 500 mg 4 times per day for 14 days, plus bowel lavage on day 4 or day 5, or (3) oral vancomycin 500 mg 4 times per day for 4 or 5 days, followed by bowel lavage and infusion of donor feces. Those who had a recurrence after fecal infusion had a second infusion from a different donor, while those who had a recurrence after antibiotics alone were treated with donor feces off protocol. The mean age of patients was 70 years, 18 of 41 were women, and more than half had acquired the C. difficile infection in the hospital. Groups were balanced at randomization, and analysis was by intention to treat. The study was stopped early when a significant advantage of donor feces infusion was seen over antibiotics alone. The percentage cured without relapse was 81.3% after the initial infusion of donor feces, compared with 31% in those receiving vancomycin alone, and 23% receiving vancomycin plus lavage (P < .01 for both comparisons; number needed to treat = 2). Adverse events in the donor feces group were diarrhea in 15 of 16, and abdominal cramping in 5 of 16.

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