Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events
Serious adverse reactions attributable to FMT occurred in 1.9% of procedures for recurrent C. difficile infection, with higher serious adverse event rates in extended access programme patients.
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What the study showed
The study tracked adverse events in 325 patients (397 FMTs) over 7 years, identifying serious adverse reactions (SARs) in 6 of 322 FMTs for rCDI (1.9%). Mild gastrointestinal adverse events were common: 61% in rCDI patients and 34% in extended access patients. Serious adverse events were more frequent in the extended access group, reflecting greater immunosuppression and comorbidity burden.
How it was done
Prospective observational cohort of all patients receiving frozen donor faecal suspensions from the Netherlands Donor Feces Bank between May 2016 and December 2023. Adverse events were physician-reported and recorded at 3 weeks, 3 months, and 6 months post-FMT.
Risk of bias
Only the abstract is accessible; complete SAR data for the EAP group and detailed causality assessment methodology are unavailable. The observational design without a control group limits causal inference regarding adverse events.
What this study does NOT prove
The study does not demonstrate that the proposed framework reduces infectious adverse events compared to unstructured approaches.
In clinical practice
A 1.9% SAR rate in rCDI and higher serious event frequency in immunocompromised patients support careful patient selection and structured follow-up protocols. The proposed EU SoHO-aligned biovigilance framework may standardize reporting and reduce underreporting.
Limitations
Only the abstract is accessible; complete SAR data for the EAP group and detailed causality assessment methodology are unavailable. The observational design without a control group limits causal inference regarding adverse events.
Technical appendix
Version history
- 1.0 · 2026-07-13 — Auto-generated under Evidence Standard v1.0
Paid access: structured summary from public metadata; consult the original study at the source.