Evidence map›Paper›PMID 38188575›Full record

ReviewFrontiers in microbiology2023

Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics.

Irina Spacova, Sylvie Binda, Jessica Anne Ter Haar, Solange Henoud, Sophie Legrain-Raspaud, James Dekker, Jordi Espadaler-Mazo, Philippe Langella, Rebeca Martín, Marco Pane and 1 more

Open access · goldAbstract readReview
In one paragraph

Review in Frontiers in microbiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 1 pooled it
15.5field-weighted citation impact, top 1% of its field
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

52 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.

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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

11 authors at 6 institutions in 5 countries.

Irina SpacovaResearch Group Environmental Ecology and Applied Microbiology, Department of Bioscience Engineering, University of Antwerp, Antwerp, Belgium.
Sylvie BindaRosell Institute for Microbiome and Probiotics, Montreal, QC, Canada.
Jessica Anne Ter HaarInternational Probiotics Association, Los Angeles, CA, United States.
Solange HenoudRosell Institute for Microbiome and Probiotics, Montreal, QC, Canada.
Sophie Legrain-RaspaudGnosis by Lesaffre, Marcq-en-Baroeul, France.
James DekkerFonterra Research and Development Centre Co., Ltd., Palmerston North, New Zealand.
Jordi Espadaler-MazoDepartment of R&D, AB-Biotics SA (Kaneka Group), Barcelona, Spain.
Philippe LangellaUniversité Paris-Saclay, INRAE, AgroParisTech, Micalis Institute, Jouy-en-Josas, France.
Rebeca MartínUniversité Paris-Saclay, INRAE, AgroParisTech, Micalis Institute, Jouy-en-Josas, France.
Marco PaneProbiotical Research, Novara, Italy.
Arthur C OuwehandGlobal Health and Nutrition Science, IFF Health, Kantvik, Finland.
AgroParisTech · FRAB-Biotics (Spain) · ESFonterra (New Zealand) · NZLesaffre (France) · FRProbiotical (Italy) · ITUniversity of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Application of beneficial microorganisms as probiotics targets a broad range of intended uses, from maintaining health and supporting normal bodily functions to curing and preventing diseases. Currently, three main regulatory fields of probiotic products can be defined depending on their intended use: the more similar probiotic foods and probiotic dietary supplements, and live biotherapeutic products. However, it is not always straightforward to classify a probiotic product into one of these categories. The regulatory nuances of developing, manufacturing, investigating and applying each category of probiotic products are not universal, and not always apparent to those unfamiliar with the various global probiotic regulatory guidelines. Various global markets can be significantly different regarding legislation, possible claims, market value and quality requirements for the development and commercialization of probiotic products. Furthermore, different probiotic product categories are also linked with variable costs at different stages of product development. This review outlines the current landscape comparing probiotic foods, probiotic dietary supplements, and live biotherapeutics as probiotic products from a regulatory lens, focusing on product development, manufacturing and production, and clinical research agenda. The aim is to inform and promote a better understanding among stakeholders by outlining the expectations and performance for each probiotic product category, depending on their intended use and targeted geographical region.

Indexed as

clinical trialsdrugmanufacturingpharmabioticsprobioticproduct developmentregulationsupplement

Identifiers

PMID38188575
PMCPMC10770255
OpenAlexW4389938247

What OpenQuestion 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 OpenQuestion graph.