ProBioPlus 4 Food
Leading company: Principium Europe S.r.l.
Industrial company: Far.Co.S. S.r.l. – Farcoderm S.r.l. – Gricar Chemical S.r.l. – It Food S.r.l.
Research entity: Università degli Studi di Milano-Bicocca
Financial sustain: € 1.446.250,00
The ProBioPlus 4 Food project is part of a wider collaboration between university and companies operating in the nutraceutical sector in Lombardy. The network coordinated by ROELMI HPC (formerly Principium Europe) shares efforts to develop new high-tech and high-quality probiotic foods (or supplements) in order to reach a high market attractiveness.
The first step of the project was to identify new formulations of probiotic bacteria to be administered in functional foods or supplements. The project was focused particularly towards the two main types of probiotic bacteria Lactobacillus and Bifidobacterium. Through the microbiological research conducted by the Department of Biotechnology and Biosciences (BtBs) of the University of Milan – Bicocca, it was possible to identify 7 new probiotic strains, characterizing them through genetic fingerprinting and phenotypic profiling. All strains resulted safe for human applications and have no acquired or transmissible resistance to commonly used antibiotics. Investigation of human beneficial properties were asserted by in-vitro tests. These tests permitted the selection of strains showing useful abilities, such as group B vitamins production, lactose digestion, antimicrobial activity against pathogenic bacteria and antioxidant potential. Moreover, through human cell line testing, the strains displayed the ability to adhere to the intestinal mucosa and to exert immunomodulation and antioxidant actions.
BtBs researchers set up a novel method for assessing the bacterial composition of intestinal and vaginal microbiome based on quantitative real-time PCR technique.
Two different formulations, with multiple probiotic strains, were then performed and investigated through a two-arm, randomized, and placebo controlled clinical trial. The study, conducted at CompLife group’s clinic (formerly Farcoderm srl), was registered with international identification number ISRCTN15032219. The two synergistic formulations of oral administered probiotics have been effective in reducing the symptoms associated with irritable bowel syndrome (IBS) and have been shown to be able to selectively modulate the intestinal microbial composition. This work highlights how probiotic oral intake may result in increased probiotic cells and their colonization in the intestinal compartment. This increase was appreciable already after 10 days treatment.
Through preclinical screening, we demonstrate that the abundance of probiotic species in the vaginal microbiome varies depending on the oral intake of our probiotic formulations. Probiotics play a key role in vaginal microbiota’s healthy: producing lactic acid, lowering the vaginal pH and preventing colonization by potentially pathogenic microorganisms. This discovery allowed us to apply for international patent protection for the three strains composition (L. plantarum LP – PBS067, L. rhamnosus LRh – LRH020, B. Lactis BL – BL050). The second objective achieved during the P4F project was to improve the resistance of strains through their microencapsulation, a technique that provides a physical barrier around the cells to protect them from unfavorable environmental conditions. Exploring novel coating materials, different manufacturing processes helps to develop a new microencapsulation technology. Successfully, we added a β-glucan with immunomodulatory properties, into the microcapsule together with probiotics. Such novelties led to a national patent application. Finally, were successful conducted different probiotic stability tests in new galenic preparations, like capsules, tablets, stick and oil suspensions. All the preparations were tested and subjected to sensory evaluation (taste, color, appearance). Novel food applications were also investigated: probiotics were inserted into anhydrous hydrating creams, fruit preparations for baked goods, semicandled fruit for ice creams.
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