Evidence map›Paper›PMID 40155609›Full record

ReviewNPJ biofilms and microbiomes2025

The regulatory framework for microbiome-based therapies: insights into European regulatory developments.

Julie Rodriguez, Magali Cordaillat-Simmons, Bruno Pot, Céline Druart

Abstract readReview
In one paragraph

Review in NPJ biofilms and microbiomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
–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

37 citing papers in PubMed.

  1. Review
  2. Review
  3. Fecal Microbiota Transplantation BeyondJournal of Korean medical science · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Gut microbiota in health and disease.Molecular biomedicine · 2026
    Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. The Gut-Liver Axis in Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Insights to Precision Therapeutics.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Review
  18. Article
  19. Review
  20. Decoding the power of the microbiome in human health.Frontiers in cellular and infection microbiology · 2026
    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

4 authors.

Julie RodriguezPharmabiotic Research Institute (PRI), Narbonne, France. julie@pharmabiotic.org.
Magali Cordaillat-SimmonsPharmabiotic Research Institute (PRI), Narbonne, France.
Bruno PotPharmabiotic Research Institute (PRI), Narbonne, France.
Céline DruartPharmabiotic Research Institute (PRI), Narbonne, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The emergence of a broad spectrum of microbiome-based therapies has triggered changes in European regulatory frameworks. The first part of the review describes these innovative therapies. The second part provides an overview of the current framework and key changes introduced by the Regulation on substances of human origin (SoHO) for the development of microbiome-based therapies, highlighting the need of microbiome regulatory science to unlock the full potential of microbiome-based therapies.

Indexed as

Biological TherapyMicrobiotaEuropeFecal Microbiota TransplantationHumansProbiotics

Identifiers

PMID40155609
PMCPMC11953238

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.