Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events

V. O. Chernova; J. van Prehn; B. Groenewegen; E. van Lingen; E. J. Kuijper; M. M.C. Lambregts; E. van Nood; G. Choi; M. D. Hazenberg; J. J. Keller; E. M. Terveer

doi:10.1002/ueg2.70239

Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events

V. O. Chernova
, J. van Prehn
, B. Groenewegen
, E. van Lingen
, E. J. Kuijper
, M. M.C. Lambregts
, E. van Nood
, G. Choi
, M. D. Hazenberg
, J. J. Keller
, E. M. Terveer^*

^*Corresponding author for this work

Leiden University
University Medical Centre Groningen
Amsterdam UMC
Haaglanden Medisch Centrum

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Background and Aims:

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).

Methods:

We conducted a prospective observational cohort study of all patients receiving frozen donor faecal suspensions from the NDFB (May 2016–December 2023) for recurrent Clostridioides difficile infection (rCDI) or via an extended access programme (EAP) for non-CDI indications. (Serious) adverse events ((S)AEs) were reported by physicians and recorded at 3 weeks, 3 months, and 6 months. Serious adverse reactions (SARs) were defined as SAEs probably or definitely related to FMT.

Results:

We included 290 rCDI patients (322 FMTs) and 35 EAP patients (75 FMTs). FMT efficacy was favourable overall: 92% of rCDI patients remained free of rCDI within 8 weeks, and 49% of EAP patients achieved at least a partial response. Sixty-one per cent of rCDI patients and 34% of EAP patients had mild gastrointestinal AEs. AE incidences were comparable across groups (rCDI: 5.1 vs. EAP: 4.4 per 100 patient–weeks). SAEs were more frequent in EAP patients (0.66 vs. 0.28 per patient), reflecting higher immunosuppression and comorbidity. FMT-attributable SARs occurred after 6 of 322 FMTs (1.9%) in the rCDI group and after 3 of 75 FMTs (4.0%) in the EAP group. Two donor–derived Escherichia coli infections in EAP patients with predisposing conditions were confirmed, consistent with early donor–strain colonisation rather than a direct FMT effect. Most SAEs were unrelated.

Conclusions:

In this 7-year cohort, donor-derived infections were rare but present, particularly in non-CDI patients with substantial comorbidity, whereas overall safety remained favourable. A SoHO-compliant biovigilance protocol incorporating microbiological investigation and donor/sample traceability is essential for the safe clinical use of FMT and faecal microbiota products.

Original language	English
Article number	e70239
Journal	United European Gastroenterology Journal
Volume	14
Issue number	5
DOIs	https://doi.org/10.1002/ueg2.70239
Publication status	Published - Jun 2026

Bibliographical note

Publisher Copyright:
© 2026 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.

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Chernova, V. O., van Prehn, J., Groenewegen, B., van Lingen, E., Kuijper, E. J., Lambregts, M. M. C., van Nood, E., Choi, G., Hazenberg, M. D., Keller, J. J., & Terveer, E. M. (2026). Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events. United European Gastroenterology Journal, 14(5), Article e70239. https://doi.org/10.1002/ueg2.70239

@article{88c5b202e7884433859939e90c17e269,

title = "Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events",

abstract = "Background and Aims: 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). Methods: We conducted a prospective observational cohort study of all patients receiving frozen donor faecal suspensions from the NDFB (May 2016{\textendash}December 2023) for recurrent Clostridioides difficile infection (rCDI) or via an extended access programme (EAP) for non-CDI indications. (Serious) adverse events ((S)AEs) were reported by physicians and recorded at 3 weeks, 3 months, and 6 months. Serious adverse reactions (SARs) were defined as SAEs probably or definitely related to FMT. Results: We included 290 rCDI patients (322 FMTs) and 35 EAP patients (75 FMTs). FMT efficacy was favourable overall: 92\% of rCDI patients remained free of rCDI within 8 weeks, and 49\% of EAP patients achieved at least a partial response. Sixty-one per cent of rCDI patients and 34\% of EAP patients had mild gastrointestinal AEs. AE incidences were comparable across groups (rCDI: 5.1 vs. EAP: 4.4 per 100 patient{\textendash}weeks). SAEs were more frequent in EAP patients (0.66 vs. 0.28 per patient), reflecting higher immunosuppression and comorbidity. FMT-attributable SARs occurred after 6 of 322 FMTs (1.9\%) in the rCDI group and after 3 of 75 FMTs (4.0\%) in the EAP group. Two donor{\textendash}derived Escherichia coli infections in EAP patients with predisposing conditions were confirmed, consistent with early donor{\textendash}strain colonisation rather than a direct FMT effect. Most SAEs were unrelated. Conclusions:In this 7-year cohort, donor-derived infections were rare but present, particularly in non-CDI patients with substantial comorbidity, whereas overall safety remained favourable. A SoHO-compliant biovigilance protocol incorporating microbiological investigation and donor/sample traceability is essential for the safe clinical use of FMT and faecal microbiota products.",

author = "Chernova, \{V. O.\} and \{van Prehn\}, J. and B. Groenewegen and \{van Lingen\}, E. and Kuijper, \{E. J.\} and Lambregts, \{M. M.C.\} and \{van Nood\}, E. and G. Choi and Hazenberg, \{M. D.\} and Keller, \{J. J.\} and Terveer, \{E. M.\}",

note = "Publisher Copyright: {\textcopyright} 2026 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.",

year = "2026",

month = jun,

doi = "10.1002/ueg2.70239",

language = "English",

volume = "14",

journal = "United European Gastroenterology Journal",

issn = "2050-6406",

publisher = "John Wiley \& Sons Inc.",

number = "5",

}

Chernova, VO, van Prehn, J, Groenewegen, B, van Lingen, E, Kuijper, EJ, Lambregts, MMC, van Nood, E, Choi, G, Hazenberg, MD, Keller, JJ & Terveer, EM 2026, 'Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events', United European Gastroenterology Journal, vol. 14, no. 5, e70239. https://doi.org/10.1002/ueg2.70239

TY - JOUR

T1 - Biovigilance in Faecal Microbiota Transplantation

T2 - 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events

AU - Chernova, V. O.

AU - van Prehn, J.

AU - Groenewegen, B.

AU - van Lingen, E.

AU - Kuijper, E. J.

AU - Lambregts, M. M.C.

AU - van Nood, E.

AU - Choi, G.

AU - Hazenberg, M. D.

AU - Keller, J. J.

AU - Terveer, E. M.

PY - 2026/6

Y1 - 2026/6

N2 - Background and Aims: 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). Methods: We conducted a prospective observational cohort study of all patients receiving frozen donor faecal suspensions from the NDFB (May 2016–December 2023) for recurrent Clostridioides difficile infection (rCDI) or via an extended access programme (EAP) for non-CDI indications. (Serious) adverse events ((S)AEs) were reported by physicians and recorded at 3 weeks, 3 months, and 6 months. Serious adverse reactions (SARs) were defined as SAEs probably or definitely related to FMT. Results: We included 290 rCDI patients (322 FMTs) and 35 EAP patients (75 FMTs). FMT efficacy was favourable overall: 92% of rCDI patients remained free of rCDI within 8 weeks, and 49% of EAP patients achieved at least a partial response. Sixty-one per cent of rCDI patients and 34% of EAP patients had mild gastrointestinal AEs. AE incidences were comparable across groups (rCDI: 5.1 vs. EAP: 4.4 per 100 patient–weeks). SAEs were more frequent in EAP patients (0.66 vs. 0.28 per patient), reflecting higher immunosuppression and comorbidity. FMT-attributable SARs occurred after 6 of 322 FMTs (1.9%) in the rCDI group and after 3 of 75 FMTs (4.0%) in the EAP group. Two donor–derived Escherichia coli infections in EAP patients with predisposing conditions were confirmed, consistent with early donor–strain colonisation rather than a direct FMT effect. Most SAEs were unrelated. Conclusions:In this 7-year cohort, donor-derived infections were rare but present, particularly in non-CDI patients with substantial comorbidity, whereas overall safety remained favourable. A SoHO-compliant biovigilance protocol incorporating microbiological investigation and donor/sample traceability is essential for the safe clinical use of FMT and faecal microbiota products.

AB - Background and Aims: 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). Methods: We conducted a prospective observational cohort study of all patients receiving frozen donor faecal suspensions from the NDFB (May 2016–December 2023) for recurrent Clostridioides difficile infection (rCDI) or via an extended access programme (EAP) for non-CDI indications. (Serious) adverse events ((S)AEs) were reported by physicians and recorded at 3 weeks, 3 months, and 6 months. Serious adverse reactions (SARs) were defined as SAEs probably or definitely related to FMT. Results: We included 290 rCDI patients (322 FMTs) and 35 EAP patients (75 FMTs). FMT efficacy was favourable overall: 92% of rCDI patients remained free of rCDI within 8 weeks, and 49% of EAP patients achieved at least a partial response. Sixty-one per cent of rCDI patients and 34% of EAP patients had mild gastrointestinal AEs. AE incidences were comparable across groups (rCDI: 5.1 vs. EAP: 4.4 per 100 patient–weeks). SAEs were more frequent in EAP patients (0.66 vs. 0.28 per patient), reflecting higher immunosuppression and comorbidity. FMT-attributable SARs occurred after 6 of 322 FMTs (1.9%) in the rCDI group and after 3 of 75 FMTs (4.0%) in the EAP group. Two donor–derived Escherichia coli infections in EAP patients with predisposing conditions were confirmed, consistent with early donor–strain colonisation rather than a direct FMT effect. Most SAEs were unrelated. Conclusions:In this 7-year cohort, donor-derived infections were rare but present, particularly in non-CDI patients with substantial comorbidity, whereas overall safety remained favourable. A SoHO-compliant biovigilance protocol incorporating microbiological investigation and donor/sample traceability is essential for the safe clinical use of FMT and faecal microbiota products.

UR - https://www.scopus.com/pages/publications/105041476576

U2 - 10.1002/ueg2.70239

DO - 10.1002/ueg2.70239

M3 - Article

C2 - 42283215

AN - SCOPUS:105041476576

SN - 2050-6406

VL - 14

JO - United European Gastroenterology Journal

JF - United European Gastroenterology Journal

IS - 5

M1 - e70239

ER -

Biovigilance in Faecal Microbiota Transplantation: 7-Year Cohort Study and Framework for Microbiological Assessments of Infectious Adverse Events

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Bibliographical note

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