Abstract
A careful selection of the probiotic agent, standardization of the dose and detailed characterization of the beneficial effects are essential when considering use of a probiotic for the dietary management of serious diseases. However, changes in the manufacturing processes, equipment or facilities can result in differences in the product itself due to the live nature of probiotics. The need to reconfirm safety and/or efficacy for any probiotic product made at a different factory is therefore mandatory. Recently, under the brand VSL#3®, a formulation produced by a manufacturer different from the previous one, has been commercialized in some European countries (the UK and Holland). VSL#3 is a high concentration multi-strain preparation which has been recognized by the main Gastroenterology Associations for the dietary management of pouchitis as well as ulcerative colitis. We have compared the “original” VSL#3 produced in USA with the “newfound” VSL#3 produced in Italy. According to our results, the “newfound” VSL#3 has 130–150% more “dead bacteria” compared to the “original” product, raising concerns for the well-known association between dead microbes with adverse effects. The abilities of bacterial lysates from the two formulations to influence in vitro viability and proliferation of different tumor cell lines also resulted different. The repair of previously scratched monolayers of various adherent tumor cell lines (i.e. HT1080, and Caco-2 cells) was inhibited more significantly by the “original” VSL#3 when compared to the “newfound” VSL#3. Tumor cell cycle profile, in particular cell cycle arrest and apoptotic death of the cancer cells, further confirms that the “original” VSL#3 has a better functional profile than the “newfound” VSL#3, at least in in vitro. Our data stress the importance of the production conditions for the “newfound” VSL#3 considering that this product is intended to be used for the dietary management of patients with very serious diseases, such as chronic inflammatory bowel diseases.
Highlights
A probiotic is defined as a “live microorganism which when administered in adequate amounts confers a health benefit on the host' [1]
The following features are essential when selecting a probiotic product: i) the specific strain(s) must be characterized using appropriate phenotypic, and genotypic techniques [2] ii) the matrix in which the strains are delivered must be defined; iii) the number of live microorganisms provided in a given dose of the product must be specified, and, iv) the number of dead bacteria in the preparation must be within an acceptable range, for safety reasons
The box purchased in Italy contained the probiotic mix produced in the USA, a formulation already utilized by our group for previous publications in 2001, 2008 and 2011 and other unpublished tests [16,17,18] (“original” VSL#3)
Summary
A probiotic is defined as a “live microorganism which when administered in adequate amounts confers a health benefit on the host' [1]. Both lots of “newfound” product contained a considerably lower percentage of live cells (P
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
