title: Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics.
abstract: Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy.
authors.affiliation: International Scientific Association for Probiotics and Prebiotics, Centennial, Colorado.
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Sanders
authors.forename: Todd R
authors.initials: TR
authors.lastname: Klaenhammer
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Ouwehand
authors.forename: Bruno
authors.initials: B
authors.lastname: Pot
authors.forename: Eric
authors.initials: E
authors.lastname: Johansen
authors.forename: James T
authors.initials: JT
authors.lastname: Heimbach
authors.forename: Maria L
authors.initials: ML
authors.lastname: Marco
authors.forename: Julia
authors.initials: J
authors.lastname: Tennilä
authors.forename: R Paul
authors.initials: RP
authors.lastname: Ross
authors.forename: Charles
authors.initials: C
authors.lastname: Franz
authors.forename: Nicolas
authors.initials: N
authors.lastname: Pagé
authors.forename: R David
authors.initials: RD
authors.lastname: Pridmore
authors.forename: Greg
authors.initials: G
authors.lastname: Leyer
authors.forename: Seppo
authors.initials: S
authors.lastname: Salminen
authors.forename: Duane
authors.initials: D
authors.lastname: Charbonneau
authors.forename: Emma
authors.initials: E
authors.lastname: Call
authors.forename: Irene
authors.initials: I
authors.lastname: Lenoir-Wijnkoop
mesh_terms: D014644:Genetic Variation; D006801:Humans; D061214:Patient Safety; D019936:Probiotics / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use; D016896:Treatment Outcome
keywords: efficacy; gene expression; genetics; probiotic; regulatory; safety