Fecal transplant for recurrent C. difficile colitis (donor feces vs. vancomycin)
Trial question
What is the role of duodenal infusion of donor feces in patients with recurrent C. difficile infection?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 29
29 patients (15 female, 14 male).
Inclusion criteria: patients with recurrent C. difficile infection.
Key exclusion criteria: prolonged compromised immunity because of recent chemotherapy; HIV infection with a CD4 count < 240 cells/mm*3; prolonged use of prednisolone at a dose ≥ 60 mg/day; pregnancy; admission to an ICU; need for vasopressor medication.
Interventions
N=16 donor feces infusion (an initial vancomycin regimen 500 mg PO four times/day for 4 days, followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube).
N=13 vancomycin (500 mg PO QID for 14 days).
Primary outcome
Resolution of Clostridioides difficile infection
81%
31%
81.0 %
60.8 %
40.5 %
20.3 %
0.0 %
Donor feces
infusion
Vancomycin
Significant
increase ▲
NNT = 2
Significant increase in resolution of C. difficile infection (81% vs. 31%; RR 2.61, 95% CI 1.06 to 4.16).
Safety outcomes
No significant differences in adverse events, except for mild diarrhea and abdominal cramping in the infusion group on the infusion day.
Conclusion
In patients with recurrent C. difficile infection, donor feces infusion was superior to vancomycin with respect to resolution of C. difficile infection.
Reference
van Nood E, Vrieze A, Nieuwdorp M et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15.
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