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Supplements & functional ingredients


These candidates represent a significant proportion of the currently cultivable human gut microbiome and offer physiological functions that are not always directly conferred by bifidobacteria or lactobacilli, such as the production of butyrate, propionate, and other bioactives. Converting these species into industrially viable probiotics presents challenges as their requirement for rich growth media and anaerobic conditions adds cost and complexity, as well as investment in determining optimal fermentation and manufacturing processes over time.


Improved parameters Despite these difficulties, A. muciniphila is one of the more promising candidates. Isolated in 2004, it has been tested in pre-clinical animal models and shown to prevent development of obesity, with bacterial pasteurisation increasing stability and efficacy of the species.


“Unique combinations of prebiotics in optimised mixtures may provide the ability to create new profiles of benefits.”


Initial proof of concept studies have taken place in humans and shown that both live and pasteurised A. muciniphila is safe to use in humans and improves several metabolic parameters. Live A. muciniphila is already on the market in a multispecies synbiotic preparation, containing inulin, Bifidobacterium longum subsp. infantis and other anaerobic bacteria and was shown to improve glucose levels in type two diabetics.


A. muciniphila has been isolated and tested to prove it is safe for humans to use.


In addition to the core heartlands of gut and immune health, emerging target conditions for probiotic therapy include subfertility, liver disease,


mood disorders, cognition, oral health, asthma, metabolic disease, hypocholesterolemia, and obesity. Significant emphasis will be placed on investigating the safety of novel species and genera considered for the development of new probiotic products. Many commonly exploited and currently available probiotic strains benefit from a generally recognised as safe (GRAS) status in the US, or belong to species with qualified presumption of safety (QPS) status with the European Food Safety Authority (EFSA) – yet this is not yet the case for other candidate-novel probiotic species that have no history of use.


Submission through GRAS, QPS, and novel food frameworks may enable a path to commercialisation, and for pharmaceutical applications. Novel regulatory frameworks are emerging, for example, the live biotherapeutic products category being defined by the Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines. A complete characterisation of strains from these new species will likely be required, comprising retrospective analysis of possible human disease linked with the taxa considered, full genome sequence, antibiotic-resistant genes, toxin genes, transferrable genetic elements, virulence factors, proven safety in animal models, pharmacokinetics, pharmacodynamics, and phase I–III trials.


The seal of approval


Many live biotherapeutic products with appropriate clinical evidence will fall within the current scientific definition of probiotics, albeit attracting specific regulatory attention. The discovery of defined therapeutic microbial consortia with network interactions and synergistic effects will augment the development of single-strain organisms in the future and remain in the scope of the current probiotic definition, if well characterised. Adjacent to probiotics, postbiotics1 – microbial fragments and metabolites – have been shown to share many, though not all, mechanisms of their live probiotic counterparts. Some new promising gut isolates will also most likely be commercialised under the postbiotic category, such as the aforementioned pasteurised A. muciniphila or bioactive proteins from this species that have shown beneficial effects.


At the instigation of the prebiotic concept for gut microbiota management, and for many years since, the primary premise of prebiotics has been selectively fermented carbohydrates acting in the colon and modulating levels of resident lactobacilli and bifidobacteria said to elicit health effects. In recent years, omics techniques have improved mechanistic in vitro and in vivo research, as well as human clinical


34 Ingredients Insight / www.ingredients-insight.com


Tatiana Frank/Shutterstock.com


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