Complexities and Pitfalls in the Production of Multispecies Probiotics: The Paradigmatic Case of VSL#3 Formulation and Visbiome

This chapter highlights the different parameters by which probiotic preparations are characterized and shows how changes to formulations and/or manufacturing processes can seriously affect the specific properties on which the product's efficacy is based. As a paradigmatic example, we have examined the case of the multispecies probiotic product VSL#3, which is currently also manufactured under a process different from the original one developed by De Simone in the 1990s. We report analyses comparing the two products. These analyses strongly support the hypothesis that the manufacturing changes affecting the lately marketed formulation result in differences from the original De Simone formulation, so that the efficacy studies carried out on the latter are not generalizable to the lately marketed product.