title: Safety assessment of probiotics for human use.
abstract: The safety of probiotics is tied to their intended use, which includes consideration of 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 alive 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 contrasted with the long history of safe use of many of these microbes in foods.
authors.affiliation: Dairy and Food Culture Technologies, Centennial, CO, USA. mes@mesanders.com
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Sanders
authors.forename: Louis M A
authors.initials: LM
authors.lastname: Akkermans
authors.forename: Dirk
authors.initials: D
authors.lastname: Haller
authors.forename: Cathy
authors.initials: C
authors.lastname: Hammerman
authors.forename: James
authors.initials: J
authors.lastname: Heimbach
authors.forename: Gabriele
authors.initials: G
authors.lastname: Hörmannsperger
authors.forename: Geert
authors.initials: G
authors.lastname: Huys
authors.forename: Dan D
authors.initials: DD
authors.lastname: Levy
authors.forename: Femke
authors.initials: F
authors.lastname: Lutgendorff
authors.forename: David
authors.initials: D
authors.lastname: Mack
authors.forename: Phoukham
authors.initials: P
authors.lastname: Phothirath
authors.forename: Gloria
authors.initials: G
authors.lastname: Solano-Aguilar
authors.forename: Elaine
authors.initials: E
authors.lastname: Vaughan
mesh_terms: D000818:Animals; D001419:Bacteria / Q000737:chemistry / Q000235:genetics / Q000472:pathogenicity; D003257:Consumer Product Safety; D004358:Drug Therapy; D059022:Food Safety; D006801:Humans; D007422:Intestines / Q000276:immunology / Q000382:microbiology*; D019936:Probiotics / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic