Revisiting the valorization of probiotics as possible clinical modalities to improve human health

Our life expectancy has increased considerably, but these extra life years are not always spent in good health. To increase our resilience to modern health problems, there is a need for intervention, preferably following a One Health approach including interactions with microbes from our environment. This is where the gut microbiota comes into play, which has been associated with the development of metabolic, inflammatory, and mental and neurological disorders that are becoming more prevalent. A way to modulate the gut microbiota is through probiotics, defined as live microorganisms, that when administered in adequate amounts, confer a health benefit on the host. The mechanisms through which these benefits are expressed are highly complex and vary between different strains of bacteria and product types, among other factors. This makes the transition from scientific knowledge to a societally beneficial product, or valorization, of probiotics a difficult process. Therefore, the aim of this thesis is to create insight into the status of valorization of probiotics to improve human health outcomes as determined by the ability of innovators to address predefined barriers, by investigating trends in nutrition, lifestyle habits, disease prevalence, intellectual property, and clinical research and practices. Firstly, the extent to which innovators in the field of probiotics can link their effort to broader societal health challenged was assessed. Focusing on the 21st century, the prevalence of metabolic disease has increased disproportionally fast compared to nutrient and total caloric intake. This indicates that there are possible unaddressed factors in our seemingly declining health status, which could relate to the gut microbiota. However, direct links could not be uncovered. Secondly, the extent to which different types of innovators are still engaged with probiotic research and development was assessed. For insight into probiotic research on specific health indications, clinical trial and patent records were studied for infectious diseases and microbiota-gut-brain axis-related conditions. The number of clinical trials with probiotics has increased greatly, and it was found that the field is growing towards a set of specific locations and indications. However, despite this growth, there seems to have been a stagnation in the transition from intellectual property protection to clinical research. Thirdly, the extent to which innovators have addressed market entry barriers was assessed. To gain insight into the potential post-market adoption of probiotics as clinical modalities, a meta-analysis was executed. It was found that despite a high heterogeneity due to differing study designs and probiotic products, usage of probiotics could be beneficial for the improvement of cognitive functioning and lowering of inflammatory cytokines. In a pilot survey among dietitians, it was found that chronic age-related inflammation is already being addressed in practice through dietary interventions including probiotics. These studies indicate that despite the interest from healthcare professionals, barriers regarding the demonstration of efficacy and accompanying regulations are still persistent. Altogether, the findings of this thesis suggest that there is potential when it comes to the use of probiotics to improve human health status. However, the potential is still not fully exploited, and therefore probiotics are still not widely adopted as clinical modalities, ultimately indicating that the valorization cycle is still not optimal. To conclude, there appears to be a growing interest from healthcare professionals in applying probiotics in their treatment plans and recommendations, and the evidence base regarding the effects and underlying mechanisms of probiotics on the gut microbiota and human health is continuously growing, although at a slower rate. But before the valorization cycle of probiotics can be fully optimized, it will be necessary to address the persistent barriers associated with probiotics research, development, and marketing.

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