Effect of Human Milk Oligosaccharide-based synbiotics on neurodevelopment of HIV-exposeduninfected children

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ABSTRACT This is a request for supplement funding to the MIGH-T MO study (i.e. R01HD105492 titled: “Trial of Human Milk Oligosaccharide-based synbiotics for HIV-exposed uninfected children”) being conducted in South Africa. This supplement study is related to the parent study aims of studying the effect of the intervention on outcomes of growth and morbidity, by focusing on neurodevelopment. Neurodevelopment is an important part of growth and morbidity, thus relevant to the parent study aims. Of relevance to the parent study population of children who are HIV-exposed uninfected (CHEU), there is data from multiple settings including South Africa that show impaired neurodevelopment in CHEU compared to children who are HIV-unexposed uninfected (CHUU), and an intervention to improve neurodevelopment outcomes are currently lacking for CHEU. Importantly, animal model data and observational data from humans suggest that certain human milk oligosaccharides, such as 2’- Fucosyllactose being used in this study, are positively associated with neurodevelopment. Thus, our study provides an important opportunity to test the effect of the human milk oligosaccharide-based intervention on CHEU neurodevelopment using a randomized trial design. Overall, we hypothesize that the intervention will improve neurodevelopment in CHEU. Our findings would inform on whether the synbiotic could be an effective intervention to reduce growth deficits and morbidity, as they relate to neurodevelopment, in CHEU.