P884 No shared mechanisms among “old” and “new” VSL#3: Implications for claims and guidelines

Abstract

In the probiotic field, not all probiotics function in the same manner. While the strain-specificity of probiotic effects has been accepted as a fundamental principle, the fact that the strains function in different ways depending from the production sites, is less known. Considering the body of research conducted on clinical effects of probiotics for the dietary prevention and treatment of IBD supporting the conclusion that some specific formulations may have benefits, it is important to inform doctors and patients that independently from the genetics, the change of the processing or product formulation may lead to a different outcome in terms of efficacy and safety. The Author, the inventor of the high concentration multistrain preparation reported in the past literature as VSL#3, will present data showing that the “new” formulation commercialised under the brand VSL#3® (the VSL#3 brand is property of Actial Srl, Italy) and now produced in Italy is completely different from the “original” formulation produced in USA, which is the one previously studied in patients with IBD and endorsed by the ECCO guidelines. Results obtained with proteomics, metabolomics and lipidomics by comparison between the original US-made formulation and the “new” Italy-made formulation. Certain metabolic pathways and molecular mechanisms present in the “original” VSL#3 are clearly no more present in the “new” Italy-made VSL#3. Molecular mechanisms of VSL#3 are different after changing the manufacturing site from USA to Italy Recent data have shown that the “new” Italy-made VSL#3 is different from the “original” formulation.1–3 The proteomics, metabolomics and lipidomics confirm that the two formulations do not have similar underlying core mechanisms. All together these data confirm the need for clinical trials in IBD patients with the Italy-made formulation to establish the efficacy and safety of the “new” VSL#3. In addition, since the information from the previous trials cannot be applied or extrapolated to this “new” VSL#3, ECCO has to take an action to update its Guidelines. 1. Cinque B. Production conditions affect the in vitro anti-tumoral effects of a high concentration multi-strain probiotic preparation. 2016. https://doi.org/10.1371/journal.pone.0163216. 2. Biagioli M. Metabolic variability of a multispecies probiotic preparation impacts on the anti-inflammatory activity. 2017. 10.3389/fphar.2017.00505. 3. Trinchieri V. Efficacy and safety of a multistrain probiotic formulation depends from manufacturing. 2017. 10.3389/fimmu.2017.01474.