Evidence map›Paper›PMID 40501442›Full record

ReviewGut microbes2025

The ladder of regulatory stringency and balance: an application to the US FDA's regulation of bacterial live therapeutics.

Moshe Maor, Hilit Levy Barazany, Ilana Kolodkin-Gal

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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

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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

3 authors.

Moshe MaorLauder School of Government, Diplomacy & Strategy, Reichman University, Herzliya, Israel.ORCID 0000-0003-0411-2977
Hilit Levy BarazanyScojen Institute for Synthetic Biology, Dina Recanati School of Medicine, Reichman University, Herzliya, Israel.
Ilana Kolodkin-GalScojen Institute for Synthetic Biology, Dina Recanati School of Medicine, Reichman University, Herzliya, Israel.ORCID 0000-0002-8464-5660

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The three main types of live bacterial therapies - probiotics, fecal/microbiome transplants, and engineered bacterial therapies - hold immense potential to revolutionize medicine. While offering targeted and personalized treatments for various diseases, these therapies also carry risks such as adverse immune reactions, antibiotic resistance, and the potential for unintended consequences. Therefore, developing and deploying these therapies necessitates a robust regulatory framework to protect public health while fostering innovation. In this paper, we propose a novel conceptual tool - the

Indexed as

Fecal Microbiota TransplantationProbioticsBacteriaGastrointestinal MicrobiomeHumansUnited StatesUnited States Food and Drug AdministrationC difficileFDAfecal microbiota transplantsgenetically modified organismsprobioticsregulation

Identifiers

PMID40501442
PMCPMC12164374

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.