Evidence map›Paper›PMID 25574076›Full record

ArticleWorld journal of gastroenterology2015

Fecal transplant policy and legislation.

Dinesh Vyas, Apoorva Aekka, Arpita Vyas

Abstract read
In one paragraph

Article in World journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

17 citing papers in PubMed.

  1. Article
  2. Review
  3. In Vitro and In Vivo Anti-Journal of microbiology and biotechnology · 2022
    Article
  4. Article
  5. A probiotic yeast-based immunotherapy againstScience translational medicine · 2020
    Article
  6. Review
  7. Review
  8. Faecal microbiota transplantation in patients withWorld journal of gastroenterology · 2017
    Article
  9. Oral microbiota transplant: a potential new therapy for oral diseases.Journal of the California Dental Association · 2017
    Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Biome engineering-2020.Microbial biotechnology · 2016
    Review
  16. Article
  17. Article
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

3 authors.

Dinesh VyasDinesh Vyas, Apoorva Aekka, Arpita Vyas, College of Human Medicine, Michigan State University, East Lansing, MI 48912, United States.
Apoorva AekkaDinesh Vyas, Apoorva Aekka, Arpita Vyas, College of Human Medicine, Michigan State University, East Lansing, MI 48912, United States.
Arpita VyasDinesh Vyas, Apoorva Aekka, Arpita Vyas, College of Human Medicine, Michigan State University, East Lansing, MI 48912, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fecal microbiota transplantation (FMT) has garnered significant attention in recent years in the face of a reemerging Clostridium difficile (C. difficile) epidemic. Positive results from the first randomized control trial evaluating FMT have encouraged the medical community to explore the process further and expand its application beyond C. difficile infections and even the gastrointestinal domain. However promising and numerous the prospects of FMT appear, the method remains limited in scope today due to several important barriers, most notably a poorly defined federal regulatory policy. The Food and Drug Administration has found it difficult to standardize and regulate the administration of inherently variable, metabolically active, and ubiquitously available fecal material. The current cumbersome policy, which classifies human feces as a drug, has prevented physicians from providing FMT and deserving patients from accessing FMT in a timely fashion, and subsequent modifications seem only to be temporary. The argument for reclassifying fecal material as human tissue is well supported. Essentially, this would allow for a regulatory framework that is sufficiently flexible to expand access to care and facilitate research, but also appropriately restrictive and centralized to ensure patient safety. Such an approach can facilitate the advancement of FMT to a more refined, controlled, and aesthetic process, perhaps in the form of a customized and well-characterized stool substitute therapy.

Indexed as

Health PolicyMicrobiotaAnimalsBiological TherapyClostridioides difficileEnterocolitis, PseudomembranousFecesHumansIntestinesPatient SafetyRisk AssessmentRisk FactorsTreatment OutcomeClostridium difficileFecal microbiota transplantationStool therapyToxin

Identifiers

PMID25574076
PMCPMC4284361

What OpenQuestion holds

Textmetadata
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.