The Rigorous Screening and Ethics of Donor for Faecal Microbiota Transplantation in China

Abstract Background: Faecal microbiota transplantation (FMT) is a safe and effective therapy for recurrent Clostridium difficile infections and some gastrointestinal and systemic diseases. However, the risks of FMT and the selection process of suitable donors remain insufficiently characterized. The eligibility rate for screening, underlying microbial basis, and core ethical issues of stool donors for FMT are yet to be elucidated in China. Results：The potential stool donors were screened from December 2017 to December 2019 with the help of an online survey, clinical assessments, and stool and blood testing. Bioinformatics analyses were performed, and the composition and stability of gut microbiota in stool obtained from eligible donors were dynamically observed using metagenomics. Meanwhile, we build a donor microbial evaluation index (DoMEI) for stool donor screening. In the screening process, we also focused on ethical principles and requirements. Of the 2071 participants, 66 donors were selected via the screening process (3.19% success rate). Although there were significant differences in gut microbiota among donors, we found that the changes in the gut microbiota of the same donor were typically more stable than those between donors over time. Conclusions: The DoMEI provides a potential reference index for stool donor re-evaluation. In this retrospective study, we summarised the donor recruitment and screening procedure for FMT in China. Based on the latest advances in this field, we carried out a rigorous faecal microbiota donor screening process.