Evidence map›Paper›PMID 34316559›Full record

ReviewInfection prevention in practice2020

Regulation, risk and safety of Faecal Microbiota Transplant.

Blair Merrick, Liz Allen, Nur Masirah M Zain, Ben Forbes, Debbie L Shawcross, Simon D Goldenberg

Open access · goldAbstract readReview
In one paragraph

Review in Infection prevention in practice, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 4 pooled it
1.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 4 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Fecal Microbiota Transplantation BeyondJournal of Korean medical science · 2026
    Review
  8. Review
  9. Article
  10. Gut microbiota modulation of systemic immunity and cancer immunotherapy: mechanisms, evidence, and therapeutic implications.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026
    Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Microbiome-Genome Crosstalk in Colorectal Cancer: Colibactin Signatures andInternational journal of molecular sciences · 2026
    Review
  17. Review
  18. Review
  19. Review
  20. Review

46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Blair MerrickCentre for Clinical Infection and Diagnostics Research (CIDR), King's College, London and Guy's & St. Thomas' NHS Foundation Trust, UK.
Liz AllenEarly Clinical Development Centre of Excellence, IQVIA, Reading, UK.
Nur Masirah M ZainInstitute of Pharmaceutical Science, School of Cancer and Pharmaceutical Sciences, King's College, London, UK.
Ben ForbesInstitute of Pharmaceutical Science, School of Cancer and Pharmaceutical Sciences, King's College, London, UK.
Debbie L ShawcrossInstitute of Liver Studies, Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Simon D GoldenbergCentre for Clinical Infection and Diagnostics Research (CIDR), King's College, London and Guy's & St. Thomas' NHS Foundation Trust, UK.
King's College London · GBGuy's and St Thomas' NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

From its origins as a left-field, experimental, and even "maverick" intervention, faecal microbiota transplantation (FMT) is now a well-recognised, accepted, and potentially life-saving therapeutic strategy, for the management of recurrent Clostridiodes difficile infection (rCDI). It is being investigated as a treatment for a growing number of diseases including hepatic encephalopathy and eradication of antimicrobial resistant organisms, and the list of indications will likely expand in the future. There is no universally accepted definition of what FMT is, and its mechanism of action remains incompletely understood; this has likely contributed to the breadth of approaches to regulation depending on interpretation. In the UK FMT is considered a medicinal product, in North America, a biological product, whereas in parts of Europe, it is considered a human cell/tissue product. Regulation seeks to improve quality and safety, however, lack of standardisation creates confusion, and overly restrictive regulation may hamper widespread access and discourage research using FMT. FMT is generally considered safe, especially if rigorous donor screening and testing is conducted. Most short-term risks are associated with the delivery method (e.g. colonoscopy). Longer term risks are less well described but longitudinal follow-up of treated cohorts is in place to assess for this, and no signal towards harm has been found to date. Rarely it has been associated with adverse outcomes including the transmission of antibiotic resistant bacteria, and even death. It is vital patients undergoing FMT are well informed to the currently appreciated risks and benefits before proceeding.

Indexed as

Biological agentFaecal microbiota transplantation (FMT)Human tissue/ cell productMedicinal productRegulationSafety

Identifiers

PMID34316559
PMCPMC7280140
OpenAlexW3034922513

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.