Evidence map›Paper›PMID 36206977›Full record

ReviewRegulatory toxicology and pharmacology : RTP2022

Considerations for determining safety of probiotics: A USP perspective.

Amy L Roe, Marie-Eve Boyte, Chris A Elkins, Virginia S Goldman, James Heimbach, Emily Madden, Hellen Oketch-Rabah, Mary Ellen Sanders, Jay Sirois, Amy Smith

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Regulatory toxicology and pharmacology : RTP, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers.

0numbers the graph read from it
0cells of the map it votes in
55citing 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

55 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

10 authors.

Amy L RoeThe Procter & Gamble Company, Cincinnati, OH, USA. Electronic address: roe.al@pg.com.
Marie-Eve BoyteNutraPharma Consulting Services Inc, Quebec, Canada.
Chris A ElkinsDivision of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Virginia S GoldmanDepartment of Dietary Supplements and Herbal Medicines, Science Division, US Pharmacopeial Convention, Rockville, MD, USA.
James HeimbachJHeimbach, LLC, Port Royal, VA, USA.
Emily MaddenDepartment of Dietary Supplements and Herbal Medicines, Science Division, US Pharmacopeial Convention, Rockville, MD, USA.
Hellen Oketch-RabahDepartment of Dietary Supplements and Herbal Medicines, Science Division, US Pharmacopeial Convention, Rockville, MD, USA.
Mary Ellen SandersInternational Scientific Association for Probiotics and Prebiotics, Sacramento, CA, USA.
Jay SiroisConsumer Health Products Association, Washington, DC, USA.
Amy SmithIFF Health & Biosciences, Wilmington, DE, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

A history of safe use is a backbone of safety assessments for many current probiotic species, however, there is no global harmonization regarding requirements for establishing probiotic safety for use in foods and supplements. As probiotic manufacturers are increasingly seeking to use new strains, novel species, and next-generation probiotics, justification based on a significant history of use may be challenged. There are efforts underway by a variety of stakeholders, including the United States Pharmacopeia (USP), to develop best practices guidelines for assessing the quality and safety of probiotics. A current initiative of the USP seeks to provide expert advice specific to safety considerations for probiotics. Toward this goal, this review provides a helpful summary guide to global regulatory guidelines. We question the suitability of traditional animal toxicology studies designed for testing chemicals for relevance in assessing probiotic safety. This includes discussion of the use of excessive dose levels, the length of repeated dose toxicity studies needed, and the most suitable animal species used in toxicology studies. In addition, the importance of proper manufacturing practices with regard to final product safety are also included. Thus, an outline of essential parameters of a comprehensive safety assessment for a probiotic are provided.

Indexed as

ProbioticsAnimalsDietary SupplementsAnimal testingDietary supplementsNext-generation probioticsProbioticsSafetyToxicologyUnited States Pharmacopeia

Identifiers

PMID36206977
PMCPMC10292223

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.