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

母乳低聚糖合生元对 HIV 暴露未感染儿童神经发育的影响

• 批准号: 10712590
• 负责人: Rupak Shivakoti
• 金额: $ 35.2万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10712590
• 关键词: Address; African; Age Months; Animal Model; Area; Attention; Behavior; Biological; Child; Cognition; Cognitive; Communication; Country; Data; Data Analyses; Development; Emotional; Foundations; Funding; Goals; Grant; Growth; HIV; HIV Infections; HIV-exposed uninfected infant; Hearing; Human; Human Milk; Impairment; Infant; Infant Health; Intervention; Laboratories; Language; Language Delays; Learning; Life; Link; Literature; Memory; Methods; Morbidity - disease rate; Motor; Observational Study; Oligosaccharides; Outcome; Parents; Pathway interactions; Placebos; Postpartum Period; Probiotics; Questionnaires; Randomized; Randomized, Controlled Trials; Reporting; Research Personnel; Resource-limited setting; Resources; Rodent Model; Socialization; South Africa; South African; Spain; Speech; Testing; Time; Vision; animal data; cognitive development; data modeling; effective intervention; experience; eye hand coordination; gut microbiome; high risk; human data; improved; infant gut microbiome; intervention effect; multiple datasets; neurodevelopment; parent project; randomized trial; screening; social; study population; tool; trial design

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.

摘要 这是对MIGH-T MO研究（即R 01 HD 105492，标题为：“人体试验”）的补充资金申请 为接触艾滋病毒的未受感染儿童提供基于牛奶寡糖的合生元”）。 本补充研究与研究干预对结局影响的母研究目的相关 的增长和发病率，通过专注于神经发育。神经发育是生长的重要组成部分 和发病率，因此与母体研究目的相关。与儿童的父母研究人群相关 艾滋病毒暴露未感染者（CHEU），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相比，CHEU的神经发育受损，以及 目前缺乏改善CHEU神经发育结果的干预措施。重要的是，动物 来自人类的模型数据和观察数据表明，某些人乳低聚糖，如2 '- 本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，以测试人乳寡糖为基础的干预措施对 CHEU神经发育采用随机试验设计。总的来说，我们假设干预将 改善CHEU神经发育。我们的发现将为合生元是否能有效地 在CHEU中进行干预，以减少与神经发育有关的生长缺陷和发病率。

项目成果

Feasibility Study of a Powder-Based Supplement Intervention for a future Synbiotic Trial in Breastfed Children from South Africa.

针对南非母乳喂养儿童未来合生试验的粉末补充剂干预的可行性研究。

• DOI: 10.21203/rs.3.rs-2842773/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Shivakoti,Rupak;Laughton,Barbara;Shafiq,Mehr;Schoeman,Elisma;Glashoff,RichardH;Barnabas,Shaun;Fry,Samantha;Leu,Cheng-Shiun;Wang,Shuang;Bode,Lars;Aldrovandi,Grace;Kuhn,Louise;Slogrove,AmyL
• 通讯作者: Slogrove,AmyL