Probiotic triangle of success; strain production, clinical studies and product development

Abstract

The successful development of probiotic foods and dietary supplements rests on three pillars; each with their specific challenges and opportunities. First, strain production; this depends on selecting the right strain with promising technological properties and safety profile. Further the manufacturing of the strain in a stable format at sufficiently high yield, following regulatory and customer requirements on culture media ingredients and other processing aids. The second pillar are the preclinical and clinical studies to document that the strain is a probiotic and exerts a health benefit on the host, the consumer. Especially when aiming for a regulator approved health claim, clinical studies need to be thoroughly performed; following appropriate ethical, scientific and regulatory guidelines. Finally, the probiotic will need to be incorporated in a product that can be brought to the consumer; a dietary supplement or a functional food. Because of the live nature of probiotics, specific challenges may need to be dealt with. Although experience from other strains is helpful in the process, the development is strain specific. Commercialisation and marketing of probiotics are strictly but differently regulated in most jurisdictions; defining what can and cannot be claimed.

Bifidobacterium animalis subsp. lactis HN019 Effects on Gut Health: A Review

“…These probiotic attributes may be observed more pronounced in subjects with suboptimal physiological status but are often not observed in the healthy subjects. These functional characterizations can be investigated in various in vitro and/or animal models, while ultimately, health efficacy can only be confirmed by human clinical studies ( 64 ). Although adhesion is not a pre-requisite for a strain to elicit probiotic properties, interaction with intestinal epithelial cells (IECs) and intestinal mucosa is considered important for colonization and modulation of host factors.…”

Description of a Newly Isolated Blautia faecis Strain and Its Benefit in Mouse Models of Post-Influenza Secondary Enteric and Pulmonary Infections

“…To state the safety, a convincing demonstration and arguments are required to convince the regulatory authorities with a critical genome analysis and phenotypic functional assays. Then, of production of the strain with industrial constraints could be scaled up [ 52 ]. The use of a novel bioreactor dedicated to the culture of EOS strains, which is currently being tested, could be a first step in scaling the production up (data not shown).…”

Shaping the Future of Probiotics and Prebiotics

“…There is demand for incorporation of temperature-and moisture-stable probiotics and prebiotics into novel foods and supplements, in increasing levels and complex combinations. This trend has placed a burden on the evolution of quality assurance methodologies to ensure stability, shelf life, batch consistency, and functional integrity of such bioactive ingredients [113][114][115]. Over the years, numerous studies have called into question the quality and purity of commercial probiotic products [116], and calls have been made for standardised assessment and certification tools to improve trust from end users and other stakeholders [2].…”