Evidence map›Paper›PMID 40302307›Full record

ReviewGut microbes2025

Fecal microbiota transplantation: a tale of two regulatory pathways.

Diane E Hoffmann, Gail H Javitt, Colleen R Kelly, Josbert J Keller, Simon Mark Dahl Baunwall, Christian Lodberg Hvas

Abstract readReview
In one paragraph

Review in Gut microbes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Gut microbiota in health and disease.Molecular biomedicine · 2026
    Review
  7. Observational
  8. Review
  9. Review
  10. Review
  11. Programming the tumor microenvironment through microbiome-driven mechanisms.Frontiers in cellular and infection microbiology · 2026
    Review
  12. Review
  13. Review
  14. Review
  15. Microbiome Therapeutics for Clostridioides difficile Infection.Infectious disease clinics of North America · 2025
    Review
  16. Article
  17. Review
  18. Review
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.

Diane E HoffmannUniversity of Maryland Francis King Carey School of Law, Baltimore, MD, USA.
Gail H JavittHyman, Phelps & McNamara, Washington, DC, USA.
Colleen R KellyBrigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Josbert J KellerDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, The Hague, Netherlands.
Simon Mark Dahl BaunwallDepartment of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Christian Lodberg HvasDepartment of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fecal microbiota transplantation (FMT) is a procedure involving the transfer of intestinal microbiota from a healthy donor to a patient to restore a functional intestinal microbiome. First described in modern science in 1958, the use of FMT has been practiced for decades, but only during the past dozen years have clinical frameworks and legal regulations from competent authorities been developed. Future development of microbiota-derived medical therapies will be shaped by the regulatory frameworks of various jurisdictions. This review examines the historical development and status of FMT regulations in the United States and Europe, with particular attention to their respective approaches to ensuring the safety and quality of the therapeutic product and patient access.

Indexed as

Fecal Microbiota TransplantationGastrointestinal MicrobiomeEuropeHumansUnited StatesClostridioides difficileFecal microbiota transplantationregulation

Identifiers

PMID40302307
PMCPMC12054926

What OpenQuestion holds

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LicenceCC BY-NC
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.