1345. Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen Inoculum from Unrelated Donors a Randomized, Open Label, Controlled Pilot Study
Session: Poster Abstract Session: Clinical Trials
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • 1345_IDWPOSTER_Youngster.ppt.pdf (504.2 kB)
  • Background:  Recurrent and refractory C. difficile infection (CDI) is a growing medical concern with a recent dramatic increase in the number of patients. Response to standard antimicrobial therapy is suboptimal. Fecal microbiota transplantation (FMT) has been used to reconstitute the normal microbial homeostasis in patients and has been shown to be highly effective, but is plagued with practical and aesthetic concerns hindering its use. Furthermore, recruitment and screening of donors is a lengthy process, preventing the use of FMT in acute refractory disease. Establishing a repository of prescreened donor stools has the potential to make this treatment available for a wider patient population. We aimed to investigate the clinical outcomes of FMT for relapsing CDI using a frozen suspension from unrelated donors, comparing colonoscopic and nasogastric-tube (NGT) administration.

    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.      

    Ilan Youngster, M.D.1,2, Jenny Sauk, M.D.3, Christina Pindar4, George Russell, M.D.5, Elizabeth Hohmann, MD1 and Jess Kaplan, M.D.5, (1)Infectious Diseases, Massachusetts General Hospital, Boston, MA, (2)Infectious Diseases, Boston Children's Hospital, Boston, MA, (3)Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, (4)Massachusetts General Hospital, Boston, MA, (5)Pediatric Gastroenterology and Nutrition, Massachusetts General Hospital, Boston, MA

    Disclosures:

    I. Youngster, None

    J. Sauk, None

    C. Pindar, None

    G. Russell, None

    E. Hohmann, None

    J. Kaplan, None

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