Methods: Enrollment was conducted prospectively over a 1-year period. Candidates were directed to an online registry to complete a pre-screening survey to rule out common exclusion criteria. Eligible participants were invited for a 109-point, in-person clinical assessment by a nurse or physician and overseen by an internal medicine specialist to exclude risk factors for transmissible diseases and potential microbiome-mediated conditions. Candidate donors completed stool and serologic screening by a CLIA-approved laboratory (Figure 1).
Results: Overall, 1,387 participants enrolled in the donor program. At Stage 1, candidates completed a pre-screen survey with 910 (66%) individuals excluded, commonly for abnormal body mass index, logistic constraints and recent antimicrobial use. At Stage 2, remaining participants underwent a clinical assessment with 403 (84%) participants excluded, most commonly for loss to follow-up with 235 (58%) candidates failing to attend an invited assessment. During the clinical interview, psychiatric illness, medications and infectious disease risk factors were identified as the most common reasons for exclusion. At Stage 3, remaining candidates underwent laboratory investigation with 35 (47%) candidates excluded, commonly for rotavirus and C. difficile. Overall, 39 participants qualified as stool donors resulting in a 2.8% acceptance rate (Figure 2).
Conclusion: Healthy, rigorously screened stool for use in FMT is rare with only 2.8% donors qualifying. An unanticipated, large number of asymptomatic potential donors were not eligible and logistics as well as loss to follow-up appear to be important factors for stool banks. Consensus-based guidelines are urgently needed to ensure safe standards for stool donors.
M. Osman, OpenBiome: Employee , Salary
L. Burns, OpenBiome: Employee , Salary
G. Mendolia, OpenBiome: Employee , Salary
D. Blackler, OpenBiome: Employee , Salary
J. Burgess, OpenBiome: Board Member and Employee , Salary
C. Edelstein, OpenBiome: Employee , Salary
A. Noh, OpenBiome: Employee , Salary
E. Vo, OpenBiome: Employee , Salary
E. Alm, OpenBiome: Board Member , Volunteer for 501c3 organization
M. Smith, OpenBiome: Board Member and Employee , Salary
Z. Kassam, OpenBiome: Employee , Salary
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