Applying probiotics and prebiotics in new delivery formats – is the clinical evidence transferable?

There is substantial demand for gut health products incorporating probiotics and prebiotics. They are being delivered as ingredients in an increasing range of different product formulations. While new delivery matrices are assessed for their potential impact on cell viability and prebiotic degradation, it is unknown whether they should be expected to independently alter the clinical effect of a given probiotic and prebiotic. We provide an overview of preclinical and clinical data to examine the degree to which probiotic and prebiotic efficacy may be altered by processing and incorporation into various delivery matrices. We also consider the impact of inter-individual host factors on product efficacy. We further review regulatory positions across the globe on substantiation of prebiotic and probiotic efficacy in the final product format. In vitro data suggest that the delivery matrix may interact with prebiotic and probiotic functions via various physicochemical interactions with molecular and cellular structures and changes in cellular expression. However, direct evidence to suggest these changes have a significant in vivo impact is very limited. Indeed, meta-analyses suggest a robustness of effect across delivery matrices. Regulatory expectations vary among regions, but scope typically exists for adequate scientific justification to translate probiotic or prebiotic evidence across product formats. Early evidence suggests host factors such as diet, health and microbiome status are likely to play an important role in an individual's response to a given probiotic and prebiotic. • Probiotic and prebiotic formulation changes can affect in vitro functionality. • Meta-analyses suggest a robustness of effect across different formulations. • Host microbiome, health status and meal context may influence clinical benefit. • Regulators expect scientific rationale for use of evidence across products formats. • Performance mapping can be used to assess potential matrix-related effects.