Fecal microbiota transplant for relapsing Clostridium difficile infection using a
frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot
study
#MMPMID24762631
Youngster I
; Sauk J
; Pindar C
; Wilson RG
; Kaplan JL
; Smith MB
; Alm EJ
; Gevers D
; Russell GH
; Hohmann EL
Clin Infect Dis
2014[Jun]; 58
(11
): 1515-22
PMID24762631
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BACKGROUND: Recurrent Clostridium difficile infection (CDI) with poor response to
standard antimicrobial therapy is a growing medical concern. We aimed to
investigate the outcomes of fecal microbiota transplant (FMT) for relapsing CDI
using a frozen suspension from unrelated donors, comparing colonoscopic and
nasogastric tube (NGT) administration. METHODS: Healthy volunteer donors were
screened and a frozen fecal suspension was generated. Patients with
relapsing/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. The secondary endpoint was self-reported health
score using standardized questionnaires. RESULTS: A total of 20 patients were
enrolled, 10 in each treatment arm. Patients had a median of 4 (range, 2-16)
relapses prior to study enrollment, with 5 (range, 3-15) antibiotic treatment
failures. Resolution of diarrhea was achieved in 14 patients (70%) after a single
FMT (8 of 10 in the colonoscopy group and 6 of 10 in the NGT group). Five
patients were retreated, with 4 obtaining cure, resulting in an overall cure rate
of 90%. Daily number of bowel movements changed from a median of 7 (interquartile
range [IQR], 5-10) the day prior to FMT to 2 (IQR, 1-2) after the infusion.
Self-ranked health score improved significantly, from a median of 4 (IQR, 2-6)
before transplant to 8 (IQR, 5-9) after transplant. No serious or unexpected
adverse events occurred. CONCLUSIONS: 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.
CLINICAL TRIALS REGISTRATION: NCT01704937.
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