Prospective Laboratory Evaluation of Fecal Microbiota Transplantation Donors: Results From an International Public Stool Bank

Abstract

Background. Clostridium difficile infection (CDI) is a public health threat, and fecal microbiota transplantation (FMT) is an effective therapy for recurrent CDI. Stool banks have emerged to reduce logistic complexity and enhance access to safe FMT. However, there is variability in pathogen-testing protocols and a paucity of data on the etiology of laboratory exclusions for universal stool donors. Methods. Consecutive candidate donors were evaluated from 10 January 2014 to 21 April 2016 in the greater Boston area. Candidates who passed an initial 178-point clinical assessment, including body mass index and waist circumference, were invited to undergo stool and serological-based tests at a Clinical Laboratory Improvement Amendments-certified laboratory (figure 1). Candidate donors who met the initial clinical and laboratory testing inclusion criteria were enrolled as active donors, and stool was collected for 60 days. All material collected during the 60-day period was held in quarantine until the donor passed a second identical clinical and laboratory assessment. All stool and serology panels performed in the study period on candidate and active donors were included. Results. Overall, 131 candidate donors passed clinical evaluation and proceed to have stool and serology testing. Overall, 65 pathogens were detected among 56 donors, primarily parasitic (32%), viral (34%), and bacterial (28%) pathogens (figure 2). Among ova and parasite exclusions, Blastocystis hominis (52%) and Endolimax nana (29%) were most common, despite ruling out high-risk travel exposures. Among viral pathogens, rotavirus (86%) was most common, although no overt risk factors were identified. Bacterial pathogens detected among the asymptomatic cohort also included Helicobacter pylori, vancomycin-resistant enterococcus, C. difficile, and Cryptosporid-ium. Of the 56 donors, 18 subjects (32%) had an abnormal laboratory test at their 60-day screen following a first set of normal investigations. No blood-borne infections were identified. Conclusion. Asymptomatic rotavirus and B. hominis are the most common laboratory etiologies of exclusion despite ruling out risk factors. Accordingly, FMT donors should be screened for these pathogens and continuous laboratory testing should be considered by stool banks, given the ongoing risk of asymptomatic pathogen carriage. [Figure Presented] Disclosures. K. Ling, OpenBiome: Employee, Salary; E. Koelsch, OpenBiome: Employee, Salary; N. Dubois, OpenBiome: Employee, Salary; K. O'Brien, OpenBiome: Employee, Salary; Z. Stoltzner, OpenBiome: Employee, Salary; P. Panchal, OpenBiome: Consultant, Consulting fee; Z. Kassam, OpenBiome: Employee, Salary; Finch Scientific: Consultant and Shareholder, Equity and Research support; M. Osman, OpenBiome: Employee, Salary.