Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020
Abstract
BACKGROUND: Faecal microbiota transplantation (FMT) is an effective treatment in C. difficile infection (CDI) and is currently being investigated in other diseases. There is concern around the safety of FMT and that side effects or complications may be under-reported in the medical literature. AIM: To evaluate the safety of FMT by summarising the overall reported Adverse Events (AEs) over a 20-year period METHODS: We searched EMBASE, MEDLINE, and Cochrane Library databases, and CNKI and Wanfang Data from January 2000 to April 2020. All original studies reporting FMT-related AEs were considered for inclusion. FMT-related AEs were further classified as delivery-related or microbiota-related. RESULTS: Based on the inclusion criteria, 129 studies, which included 4241 patients (5688 FMT courses), were finally eligible. The most common indication for FMT was CDI. Overall, FMT-related AEs were observed in 19% of FMT procedures. The most frequently reported FMT-related AEs were diarrhoea (10%) and abdominal discomfort/pain/cramping (7%). FMT-related serious adverse events (SAEs), including infections and deaths, have been reported in 1.4% of patients who underwent FMT (0.99% microbiota-related SAEs). Four of five FMT-related deaths were reported in patients receiving FMT via the upper gastrointestinal route. Importantly, all reported FMT-related SAEs were in patients with mucosal barrier injury. CONCLUSION: Most FMT-related AEs were mild or moderate and self-limiting. Although FMT appears to be highly safe, its methodology should be improved to reduce both delivery-related AEs and, microbiota-related AEs.
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A recent systematic review revealed that all FMT-related serious adverse events occurred in patients with damage of the mucosal barrier.
“Notably, a recent systematic review revealed that all FMT-related serious adverse events occurred in patients with damage of the mucosal barrier. 48”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [48]
FMT has shown very good safety profiles in CDI after one or a few transplantations even in immunocompromised and fragile patients.
“FMT has shown very good safety profiles in CDI after one or a few transplantations even in immunocompromised and fragile patients. 48”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [48]
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- Authors
- Marcella, C., Cui, B., Kelly, C. R., Ianiro, G., Cammarota, G., & Zhang, F.
- Affiliations
- Second Affiliated Hospital of Nanjing Medical University (CN)
- Brown University (US)
- Università Cattolica del Sacro Cuore (IT)
- Corresponding author
- Zhang, Faming
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2020-11-07
- Volume
- 53
- Issue
- 1
- Pages
- 33-42
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W3097320816
- Cited by
- 250
- References
- 74
- Citations by year
- 2026: 39 · 2025: 46 · 2024: 52 · 2023: 48 · 2022: 38 · 2021: 24 · 2020: 2
- FWCI
- 1.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Clostridium difficile and Clostridium perfringens research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- fecal microbiota transplantation, adverse events, Clostridium difficile infection, diarrhea, abdominal pain, serious adverse events, mucosal barrier injury
- MeSH terms
- Fecal Microbiota Transplantation, Clostridium Infections, Diarrhea, Feces, Humans, Recurrence, Incidence, Clostridioides difficile, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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