Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile
Els
van Nood, M.D., Anne Vrieze, M.D., Max Nieuwdorp, M.D., Ph.D., Susana
Fuentes, Ph.D., Erwin G. Zoetendal, Ph.D., Willem M. de Vos, Ph.D.,
Caroline E. Visser, M.D., Ph.D., Ed J. Kuijper, M.D., Ph.D., Joep F.W.M.
Bartelsman, M.D., Jan G.P. Tijssen, Ph.D., Peter Speelman, M.D., Ph.D.,
Marcel G.W. Dijkgraaf, Ph.D., and Josbert J. Keller, M.D., Ph.D.
- Abstract
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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.)
Enrollment and Outcomes.
Figure 2Rates of Cure without Relapse for Recurrent Clostridium difficile Infection.
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