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Randomized Controlled Trial
. 2013 Jan 31;368(5):407-15.
doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

Duodenal infusion of donor feces for recurrent Clostridium difficile

Els van Nood  1 , Anne Vrieze, Max Nieuwdorp, Susana Fuentes, Erwin G Zoetendal, Willem M de Vos, Caroline E Visser, Ed J Kuijper, Joep F W M Bartelsman, Jan G P Tijssen, Peter Speelman, Marcel G W Dijkgraaf, Josbert J Keller
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Free article
Randomized Controlled Trial

Duodenal infusion of donor feces for recurrent Clostridium difficile

Els van Nood et al. N Engl J Med. .
Free article

Abstract

Background: Recurrent Clostridium difficile infection is difficult to treat, and failure rates for antibiotic therapy are high. We studied the effect of duodenal infusion of donor feces in patients with recurrent C. difficile infection.

Methods: We randomly assigned patients to receive one of three therapies: an initial vancomycin regimen (500 mg orally four times per day for 4 days), followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube; a standard vancomycin regimen (500 mg orally four times per day for 14 days); or a standard vancomycin regimen with bowel lavage. The primary end point was the resolution of diarrhea associated with C. difficile infection without relapse after 10 weeks.

Results: The study was stopped after an interim analysis. Of 16 patients in the infusion group, 13 (81%) had resolution of C. difficile-associated diarrhea after the first infusion. The 3 remaining patients received a second infusion with feces from a different donor, with resolution in 2 patients. Resolution of C. difficile infection occurred in 4 of 13 patients (31%) receiving vancomycin alone and in 3 of 13 patients (23%) receiving vancomycin with bowel lavage (P<0.001 for both comparisons with the infusion group). No significant differences in adverse events among the three study groups were observed except for mild diarrhea and abdominal cramping in the infusion group on the infusion day. After donor-feces infusion, patients showed increased fecal bacterial diversity, similar to that in healthy donors, with an increase in Bacteroidetes species and clostridium clusters IV and XIVa and a decrease in Proteobacteria species.

Conclusions: The infusion of donor feces was significantly more effective for the treatment of recurrent C. difficile infection than the use of vancomycin. (Funded by the Netherlands Organization for Health Research and Development and the Netherlands Organization for Scientific Research; Netherlands Trial Register number, NTR1177.).

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