Fecal microbiota transplantation is best understood as an effective and inexpensive therapy for recurrent Clostridium difficile infection but fecal donor selection and screening should be periodically revised. Here, we review current recommendations for selection and screening of fecal donors for fecal microbiota transplantation. We recommend considering diabetes mellitus, prior cardiovascular events, and clinical healthcare exposure as fecal donor exclusion criteria until more is known about the association of these conditions with the human gut microbiome. We review the non-bacterial members of the human gut microbiome, associations of the gut microbiome with colorectal malignancies, the human gut resistome and how these may impact future donor screening recommendations. Collaboration between clinicians, clinical laboratory scientists, industry and regulatory agencies will be critically important for continued improvement in donor selection and screening.

Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent Clostridium difficile infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic donors present many challenges to clinical laboratories. This minireview summarizes FDA regulatory changes, principles of donor selection, and recommended laboratory screening practices for fecal microbiota transplantation.

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BackgroundFecal microbiota transplant (FMT) has been shown to be safe and effective for treatment of recurrent C. difficile infection (RCDI). The aim of this study is to determine factors impacting the durability of FMT and assess patient long-term clinical outcomes and satisfaction with the procedure.MethodsEligible patients who had received FMT for RCDI at Emory Hospital between July 1, 2012 and December 31, 2016 were contacted via telephone for a follow up survey. Of 232 patients who received FMT, 27 were deceased and 15 were unable to be reached with listed phone number. Of the remaining 190 eligible patients, 137 patients completed the survey.ResultsThe median time-period between FMT and follow up was 22 months. Median number of failed antibiotic courses for RCDI before FMT was 4. Overall, 82% (113/137) of patients experienced resolution of RCDI post-FMT (non-RCDI group) while 18% (24/137) of patients had recurrence of CDI post-FMT (RCDI group). In the RCDI and non-RCDI groups, antibiotic use post-FMT for non- C. difficile-related infections was 75% and 38% (P = 0.0004), respectively. PPI use post-FMT was 38% and 31% (P = 0.28), and probiotic use post-FMT was 63% and 41% (P = 0.026) in the RCDI and non-RCDI groups, respectively. There were 18 hospitalizations in the RCDI group and 9 were related to C. difficile complications; of the 36 hospitalizations in the non-RCDI group, only 1 was related to chronic complication of a previous C. difficile infection. Overall, 11% of patients reported improvement or resolution of medical conditions not related to CDI post-FMT while 33% reported diagnosis of a new medical condition or development of new symptoms; none of the new medical conditions or symptoms were attributable to the procedure. In all, 95% of patients indicated willingness to undergo FMT in the future if they experience another bout of C. difficile infection.ConclusionThe findings show that FMT is a highly effective treatment option for RCDI with a cure rate, defined as resolution of RCDI post-FMT or recurrence attributable to antibiotic use post-FMT, of 96% (131/137) in the study group. Furthermore, clinical outcomes and patient satisfaction post-FMT indicate the safety of the procedure.Disclosures All authors: No reported disclosures.

As understanding of the human microbiome improves, novel therapeutic targets to improve human health with microbial therapeutics will continue to expand. We outline key considerations of balancing risks and benefits, optimising access, returning key results to research participants, and potential conflicts of interest.