Evidence map›Paper›PMID 29179687›Full record

ReviewBMC gastroenterology2017

Faecal microbiota transplantation: a regulatory hurdle?

Frederick Verbeke, Yorick Janssens, Evelien Wynendaele, Bart De Spiegeleer

Abstract readReview
In one paragraph

Review in BMC gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Regulation, risk and safety of Faecal Microbiota Transplant.Infection prevention in practice · 2020
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
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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.

Frederick VerbekeDrug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, B-9000, Ghent, Belgium.
Yorick JanssensDrug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, B-9000, Ghent, Belgium.
Evelien WynendaeleDrug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, B-9000, Ghent, Belgium.
Bart De SpiegeleerDrug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, B-9000, Ghent, Belgium. Bart.DeSpiegeleer@UGent.be.ORCID http://orcid.org/0000-0002-3737-7405

Funding

Agentschap voor Innovatie door Wetenschap en Technologie 131356
6 · The paper itself

Abstract

During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosis-associated gut diseases. Competent authorities are faced with the challenge to provide adequate regulation. Currently, regulatory harmonization is completely lacking and authorities apply non-existing to most stringent requirements. A regulatory approach for faecal microbiota transplantation could be inserting faecal microbiota transplantation in the gene-, cell- and tissue regulations, including the hospital exemption system in the European Advanced Therapy Medicinal Products regulation, providing a pragmatic and efficacy-risk balanced approach and granting all patients as a matter of principle access to this therapy.

Indexed as

Clostridioides difficileFecal Microbiota TransplantationLegislation, MedicalClostridium InfectionsEuropeHumansRecurrenceUnited StatesC. difficile InfectionFaecal microbiota transplantationPseudomembranous colitisRegulatory affairs

Identifiers

PMID29179687
PMCPMC5704511

What OpenQuestion holds

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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.