Abstract

BackgroundFaecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium difficile infections and chronic gastrointestional infections. 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.ResultsThe 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.ConclusionsDoMEI provides a potential reference index for regular stool donor re-evaluation. In this retrospective study, we summarised the donor recruitment and screening procedure ensuring the safety and tolerability for FMT in China. Based on the latest advances in this field, we carried out rigorous recommendation and method which can assist stool bank and clinicians to screen eligible stool donor for FMT.

Highlights

  • Faecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridium difficile infection [1]

  • Due to invasive infections of antibiotic resistant Escherichia coli strain, one immunocompromised individual died after receiving investigational FMT [6]

  • Stool donor screening results based on our recommendations From December 2017 to December 2019, our donor selection program evaluated a total of 2071 donor candidates, including 1403 from Xiamen and 668 from Guangzhou

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Summary

Introduction

Faecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridium difficile infection (rCDI) [1]. FMT is considered as an established form of therapy for rCDI that utilises the healthy donor stool. The increasing clinical application and poorly regulated donor screening poses a risk of potentially transmitting infections. In June 2019, the US Food and Drug Administration (FDA) issued a safety alert for the potential risk of serious adverse reactions or life-threatening infections with the use of FMT. Faecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium difficile infections and chronic gastrointestional infections. 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

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