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Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events
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DOI：10.1002/ueg2.70239.png)
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Abstract
En 中文
Faecal microbiota transplantation (FMT) is increasingly used. However, no systematic approach exists to assess infectious risks after FMT, leading to underreporting. We evaluated infectious complications at the Netherlands Donor Feces Bank (NDFB) and proposed a structured biovigilance approach aligned with the EU Regulation on Substances of Human Origin (SoHO).
Keywords:
biovigilance
Clostridioides difficile infection
extended access programme
faecal microbiota transplantation
infectious adverse events
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