can vary broadly in terms of targeted popula- tion and health outcomes. However, thus far, most of them have aimed to assess the postbi- otic effects on immune function (e.g., cytokine levels, immune cell activity/counts, resistance to infection), intestinal physiology, behaviour (e.g., under chronic or prolonged stress sit- uations), cardiometabolic markers, related to cardiovascular and metabolic health (Cue- vas-González et al., 2020). To date, there are 17 clinical studies registered in the FDA Clinical Trials Database (clinicaltri- als.gov) with the keyword “postbiotics”. Of these, eight studies are investigating postbiot- ic interventions (Table 2). Most of these were designed to evaluate dietary intervention with
postbiotics, usually derived from heat-treated probiotic bacteria, sometimes added with mul- tivitamins or vitamin D. These trials have been both open-label studies, as well as randomized control trials with double, triple or quadruple blinding. Interestingly, so far, there has only been one registered dose-dependent study – a study evaluating the preventive potential of polysaccharide extract of heat killed Bifidobac- terium breve in older adults. In addition, post- biotic trials have involved healthy individuals (infants, older adults) as well as patient groups with conditions such as obesity, type 2 diabe- tes, macular degradation, and allergic rhinitis. The study durations ranged from 3 weeks to 12 months, with an average follow up period of 4 weeks.
CLINICAL TRIALS PROCESS
Trial Design & Regulation
Participant Recruitment
Trial Conduct & Analysis
Trial Report & Outreach
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