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

摘要 这是对MIGH-T MO研究(即R01HD105492，标题为：人类试验)的补充资金申请 低聚糖牛奶合生素“)正在南非进行。 这项补充研究与父母研究的目的有关，即研究干预对结果的影响。 通过关注神经发育，研究生长和发病率。神经发育是生长发育的重要组成部分 和发病率，因此与父母的研究目标相关。与儿童家长研究人群的相关性 谁是艾滋病毒暴露的未感染(CHEU)，有来自包括南非在内的多个环境的数据显示 与未感染艾滋病毒的儿童(CHUU)相比，CHU的神经发育受损，以及 目前CHEU缺乏改善神经发育结果的干预措施。重要的是，动物 模型数据和来自人类的观察数据表明，某些母乳低聚糖，如2‘- 在这项研究中使用的岩藻糖基乳糖与神经发育呈正相关。因此，我们的研究 提供了一个重要的机会来测试以母乳低聚糖为基础的干预对 使用随机试验设计的CHEU神经发育。总体而言，我们假设干预将 改善CHU的神经发育。我们的发现将为合生元是否可能是一种有效的 干预措施，以减少生长缺陷和发病率，因为它们与神经发育有关，在CHU。

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.