NIV Congres

Background: Recurrent clostridium difficile infection is difficult to treat, and failure rates for antibiotictherapy are high. We studied the effect of duodenal infusion of donor fecesin 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 bowellavage and subsequent infusion of a solution of donor feces through a nasoduodenaltube; 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 pointwas the resolution of diarrhea associated with C. difficile infection without relapseafter 10 weeks.

Results: The study was stopped after an interim analysis. Of 16 patients in the infusiongroup, 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 differentdonor, with resolution in 2 patients. Resolution of C. difficile infection occurredin 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 theinfusion group). No significant differences in adverse events among the three studygroups were observed except for mild diarrhea and abdominal cramping in the infusiongroup on the infusion day. After donor-feces infusion, patients showed increased fecal bacterial diversity, similar to that in healthy donors, with an increasein Bacteroidetes species and clostridium clusters IV and XIVa and a decrease in Proteobacteria species.

Conclusion: 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.)