Title : Efficacy and Safety of a Canadian fecal microbial transplantation (FMT) program for multiply recurrent C. difficile

Abstract:

Background: Options for recurrent C. difficile remain very limited, especially in Canada where bezlotoxumab, REBYOTA™, and VOWST™ are all not yet available.  The need for extensive donor testing in order to maintain a stool bank for FMT has been complicated by an increasing number of pathogens for screening, especially since the COVID pandemic further complicated screening protocols. We describe the safety and efficacy of FMT using enema and capsule delivery modes in a single center before and during the COVID pandemic.

Methods: Patients included adults with documented C. difficile infection (Toxin positive or PCR positive with resolution of symptoms while on oral vancomycin or fidaxomicin) with at least 3 episodes within 6 months and failing at least one pulse/taper regimen. After bowel washout with polyethylene glycol, all patients underwent either 2 FMTs one week apart via rectal enema or one administration of oral FMT using capsules. Failure was defined clinically as recurrence of diarrhea and positive C. difficile test in the absence of other contributors within 8 weeks post FMT. Anonymous donor screening was conducted as per Health Canada guidelines including SARS-COV-2 nasal and stool testing. 

Results: 111 patients underwent FMT. 9 patients had FMT via Enema and 24 via capsules between Aug 1, 2018 and March 21, 2020. The program was put on hold due to COVID-19 but restarted Aug 1, 2020- May 2023 during which time 18 patients received FMT via enema and 60 via capsules. 8/27 (30%, 95%CI 11-46%) patients failed FMT via enema but 0/84 (0%, 97.5% one sided CI 0.0-4.3%) failed capsule FMT. No clinical infections, including no COVID transmissions related to FMT occurred.

Conclusion: FMT using an anonymous donor stool bank can be safely carried out even in the context of the COVID pandemic. In our center, capsule FMT is extremely effective for recurrent C. difficile. 

Goals of Presentation

1. Describe the Clinical Problem of Multiply Recurrent C. difficile
2. Describe the approach to Fecal Microbial Transplantation in an Academic Center
3. Describe the respective efficacy of rectal enema and oral capsule based programs.

Biography:

Dr. Silverman received his medical degree and Residency in Internal Medicine at the University of Toronto. He carried out his fellowship in Infectious Diseases at the University of Manitoba in Winnipeg, and an HIV post-doctoral fellowship at the University of California, San Francisco, USA. Dr. Silverman is a pioneer in the field of Fecal Microbial Transplantation for treatment of Clostridium difficile. He was one of the first to perform the procedure in North America and he has established a large clinical and research program associated with this.

He has conducted many studies of prevention of infectious complications of injection drug use. He has over 130 peer reviewed publications including recently as a first or senior author in the Annals of Internal Medicine, New England Journal of Medicine, Nature Medicine, JAMA series and Lancet Infectious Diseases. Reviews of his work have been written in Science, Nature and reported in the International mass media including in the New York Times, BBC, CNN, The Times of India etc..