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evident
Original paper
2013NEJMInfectious Disease

van Nood fecal transplant trial

Duodenal infusion of donor feces for recurrent Clostridium difficile

RCTC. difficile infection

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Overview

Duodenal donor-feces infusion resolved recurrent C. difficile more often than vancomycin alone or vancomycin plus bowel lavage.

Clinical takeaway

For recurrent C. difficile, donor-feces infusion through a nasoduodenal tube after a short vancomycin course and bowel lavage cleared infection more often than 14 days of vancomycin, with or without lavage.

Key result

13 of 16 (81%) had resolution of C. difficile-associated diarrhea after the first infusion, versus 4 of 13 (31%) with vancomycin alone and 3 of 13 (23%) with vancomycin plus bowel lavage (P<0.001 for both comparisons).

Practice impact

Use donor-feces transplant for recurrent C. difficile rather than another vancomycin course alone.

Evidence

Study design

Randomized three-group trial of duodenal donor-feces infusion after vancomycin and bowel lavage, versus vancomycin alone, versus vancomycin with bowel lavage.

Enrollment

42

Follow-up

Resolution of C. difficile-associated diarrhea without relapse after 10 weeks.

Geography

Not listed

Clinical question

Does duodenal infusion of donor feces clear recurrent C. difficile infection more often than vancomycin, with or without bowel lavage?

Population

  • Patients with recurrent Clostridium difficile infection.

Intervention

Vancomycin 500 mg orally four times per day for 4 days, followed by bowel lavage and infusion of a solution of donor feces through a nasoduodenal tube.

Comparator

Standard vancomycin 500 mg orally four times per day for 14 days, or the same vancomycin regimen plus bowel lavage.

Primary outcome

Resolution of diarrhea associated with C. difficile infection without relapse after 10 weeks.

Donor-feces infusion resolved infection in 13 of 16 patients (81%) after the first infusion, versus 4 of 13 (31%) with vancomycin alone and 3 of 13 (23%) with vancomycin plus bowel lavage (P<0.001 for both comparisons).

p<0.001

Key results

  • The study was stopped after an interim analysis. Group sizes reported in the results were 16 in the infusion group and 13 in each vancomycin group.
  • 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 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).
  • 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.

Harms

  • 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.

Clinical Use

Practice impact

  • For recurrent C. difficile, donor-feces infusion is more effective than another vancomycin course, with or without bowel lavage.

Applicability

  • Patients with recurrent C. difficile infection. The infusion was duodenal, after 4 days of vancomycin 500 mg four times daily and bowel lavage.

Limitations

  • The trial was small (16 vs 13 vs 13 in the reported groups) and was stopped after an interim analysis.
  • The abstract does not state a single randomized total; 42 is the sum of the reported group sizes.
  • The abstract does not say why the interim analysis triggered stopping.

Common misinterpretations

  • This is a trial of recurrent infection, not a first-episode C. difficile treatment trial.
  • Bowel lavage alone does not explain the effect; vancomycin plus lavage resolved infection in only 3 of 13 patients.

Citation

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. doi:10.1056/NEJMoa1205037

The infusion of donor feces was significantly more effective for the treatment of recurrent C. difficile infection than the use of vancomycin.