[Probiotics as functional food products: manufacture and approaches to evaluating of the effectiveness]

This review concerns the issues of foodfortifications and the creation of functional foods (FF) and food supplements based on probiotics and covers an issue of approaches to the regulation of probiotic food products in various countries. The status of functional foods, optimizing GIT functions, as a separate category of FF is emphasized. Considering the strain-specificity effect of probiotics, the minimum criteria used for probiotics in food products are: 1) the need to identify a probiotics at genus, species, and strain levels, using the high-resolution techniques, 2) the viability and the presence of a sufficient amount of the probiotic in product at the end of shelf life, 3) the proof of functional characteristics inherent to probiotic strains, in the controlled experiments. The recommended by FA O/WHO three-stage evaluation procedure offunctional efficiency of FF includes: Phase I--safety assessment in in vitro and in vivo experiments, Phase II--Evaluation in the Double-Blind, Randomized, Placebo-Controlled trial (DBRPC) and Phase III--Post-approval monitoring. It is noted that along with the ability to obtain statistically significant results of the evaluation, there are practical difficulties of conducting DBRPC (duration, costs, difficulties in selection of target biomarkers and populations). The promising approach for assessing the functional efficacy of FF is the concept of nutrigenomics. It examines the link between the human diet and the characteristics of his genome to determine the influence of food on the expression of genes and, ultimately, to human health. Nutrigenomic approaches are promising to assess the impact of probiotics in healthy people. The focusing on the nutrigenomic response of intestinal microbial community and its individual populations (in this regard the lactobacilli can be very informative) was proposed.