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OBJECTIVES: Design of aggregated N-of-1 trials with the intent of identifying individuals’ unique response to probiotics by studying each individual directly. Consideration of their biochemical uniqueness will ensure sufficient data are collected on each individual to make unequivocal claims on their responses to probiotics. METHODS: In the aggregate N-of-1 trial design, measurements taken will encompass multivariate outcomes including monitoring weight, microbiome species abundance in total fecal DNA for quantitative metagenomics to evaluate microbial gene richness and quantification of short chain fatty acids; influence of probiotics on mood, cognition, depression and sleep may be measured using wireless devices. RESULTS: A pragmatic analysis approach will provide information beyond significant differences in outcomes from baseline, as well, identifying variation around outcomes for the individual. Decreasing variation over time would suggest a more stable state for a particular outcome. Data from a series of sophisticated N-of-1 studies will, therefore, provide a scientifically sound basis for the creation of a global index detailing the relationship between a nutritional response and genetic features, biochemical, behavioural and exposure levels. Physicians and health care providers can leverage this data to decide on how to manage a patient's condition, while nutraceutical companies can make more specific claims for their products. CONCLUSIONS: N-of-1 trials are a logical extension to clinical practice as physicians deal with patients as individuals with unique characteristics and treatment algorithms in a traditional clinical care setting using patient outcomes to decide if the intervention worked. N-of-1 trials and aggregated N-of-1 trials help identify factors that influence responses to nutrition that may be shared among individuals. Results from N-of-1 trials may be effectively used in Augmented Randomized double-blind Clinical Trial design to identify responders with a goal in formulating successful probiotic interventions. FUNDING SOURCES: KGK Science Inc. |
