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United States Department of Agriculture

Agricultural Research Service


Location: Diet, Genomics and Immunology Laboratory

Title: Safety assessment of probiotics for human use

item Sanders, Mary Ellen
item Akkermans, Louis
item Constable, Anne
item Haller, Dirk
item Hammerman, Cathy
item Heimbach, James
item Hormannsperger, Gabriele
item Huys, Geert
item Levy, Dan
item Lutgendorff, Femke
item Mack, David
item Phothirath, Phoukham
item Solano-aguilar, Gloria
item Vaughan, Elaine

Submitted to: Gut Microbes
Publication Type: Review Article
Publication Acceptance Date: 3/4/2010
Publication Date: 6/1/2010
Citation: Sanders, M.E., Akkermans, L.M.A., Haller, D., Hammerman, C., Heimbach, J.T., Hormannsperger, G., Huys, G., Levy, D.D., Lutgendorff, F., Mack, D., Phothirath, P., Solano-Aguilar, G., Vaughan, E. 2010. Safety assessment of probiotics for human use. Gut Microbes. 1(3):164-185.

Interpretive Summary:

Technical Abstract: The safety of probiotics is tied to their intended use, which includes consideration of the potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are living organisms when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety on the one hand contrasted with the long history of safe use of many of these microbes in foods on the other hand.

Last Modified: 10/18/2017
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