Methods: The study was reviewed and approved by the Partners IRB and the US FDA. Healthy volunteer donors were screened and sieved, concentrated frozen fecal suspension was generated. Patients with relapsing or refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT. The primary endpoint was clinical resolution of diarrhea without relapse after 8 weeks. Secondary endpoint was self-reported health score using standardized questionnaires.
Results: A total of 12 patients have been enrolled to date, 6 in each treatment arm. Patients had a median of 4 relapses (range 2-14) prior to study enrollment, with a median of 5 (range 3-15) antibiotic treatment failures. Resolution of diarrhea was achieved in 9 (75%) after a single FMT (4/6 in the colonoscopy group and 5/6 in the NGT group). Both initial failures in the colonoscopy group were retreated and obtained clinical cure after a second dose by NGT resulting in an overall success rate of 91.6%. The remaining NGT patient refused retreatment. Self-ranked health scores (scale 1-10) improved significantly from a median of 3 (range 1-6) pre-transplant to an impressive 7 (3-10) post-transplant. No serious or unexpected adverse events occurred.
Conclusion: In our initial feasibility study FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI. NGT administration appears to be as effective as colonoscopic administration.
C. Pindar, None
G. Russell, None
E. Hohmann, None
J. Kaplan, None