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Review
. 2020 Jul 24:11:1662.
doi: 10.3389/fmicb.2020.01662. eCollection 2020.

Criteria to Qualify Microorganisms as "Probiotic" in Foods and Dietary Supplements

Sylvie Binda  1 , Colin Hill  2 , Eric Johansen  3 , David Obis  1 , Bruno Pot  4 , Mary Ellen Sanders  5 , Annie Tremblay  6 , Arthur C Ouwehand  7
Affiliations
Review

Criteria to Qualify Microorganisms as "Probiotic" in Foods and Dietary Supplements

Sylvie Binda et al. Front Microbiol. .

Abstract

Still relevant after 19 years, the FAO/WHO definition of probiotics can be translated into four simple and pragmatic criteria allowing one to conclude if specific strains of microorganisms qualify as a probiotic for use in foods and dietary supplements. Probiotic strains must be (i) sufficiently characterized; (ii) safe for the intended use; (iii) supported by at least one positive human clinical trial conducted according to generally accepted scientific standards or as per recommendations and provisions of local/national authorities when applicable; and (iv) alive in the product at an efficacious dose throughout shelf life. We provide clarity and detail how each of these four criteria can be assessed. The wide adoption of these criteria is necessary to ensure the proper use of the word probiotic in scientific publications, on product labels, and in communications with regulators and the general public.

Keywords: Bifidobacterium; Lactobacillus; criterion; health efficacy; identification; live microbes; probiotic definition; safety.

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Figures

FIGURE 1
FIGURE 1
Decision tree to determine if a candidate probiotic fulfills the definition criteria.
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References

    1. Bourdichon F., Alper I., Bibiloni R., Dubois A., Laulund S., Miks M., et al. (2018). Inventory of microbial food cultures with safety demonstration in fermented food products. Bull. Int. Dairy Federat. 495 5–71.
    1. Brodmann T., Endo A., Gueimonde M., Vinderola G., Kneifel W., de Vos W. M., et al. (2017). Safety of novel microbes for human consumption: practical examples of assessment in the European Union. Front. Microbiol. 8:1725. 10.3389/fmicb.2017.01725 - DOI - PMC - PubMed
    1. Brussow H. (2019). Probiotics and prebiotics in clinical tests: an update. F1000Res 8:F1000 Faculty Rev-1157. 10.12688/f1000research.19043.1 - DOI - PMC - PubMed
    1. Buccheri R. K., Sharifi C. (2017). Critical Appraisal Tools and Reporting Guidelines for Evidence-Based Practice. Worldviews Evid. Based Nurs. 14 463–472. 10.1111/wvn.12258 - DOI - PubMed
    1. Chan A. W., Tetzlaff J. M., Altman D. G., Laupacis A., Gotzsche P. C., Krleza-Jeric K., et al. (2013). SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann. Intern. Med. 158 200–207. 10.7326/0003-4819-158-3-201302050-201302583 - DOI - PMC - PubMed

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