背景:在生命的第一年引入辅食会影响肠道微生物组的多样性。这种多样性如何影响免疫发育和健康尚不清楚。
目的:本研究评估了在随机分组后4个月,与参考对照相比,服用卡玛拉或添加香蕉粉(抗性淀粉)的卡玛拉对呼吸道感染患病率和肠道微生物组发展的影响。
方法:这项研究是双盲的,随机对照试验的母亲和他们的6个月大的婴儿(n=300)尚未开始固体。婴儿被随机分为3组:对照组(C),标准kúmara干预(K),并在婴儿大约10个月大之前每天食用添加香蕉粉产品(K)的kúmara干预。使用分层随机化对婴儿进行性别匹配。在基线(开始固体食物之前)和开始固体食物之后2和4个月(大约8和10月龄)收集数据。在每个时间点收集的数据和样本包括体重和长度,干预依从性(第2个月和第4个月),疾病和用药史,饮食摄入量(第2个月和第4个月),睡眠(日记和活动记录),产妇膳食摄入量,母乳,粪便(基线和4个月),和血液样本(基线和4个月)。
结果:该试验获得了卫生部健康与残疾伦理委员会的批准,新西兰(参考号20/NTA/9)。由于COVID-19大流行,招聘和数据收集直到2022年1月才开始。数据收集和分析预计将分别于2024年1月和2025年初结束。结果将于2024年和2025年公布。
结论:这项研究的结果将帮助我们了解特定益生元补充食品的引入如何影响微生物群和微生物物种的相对丰度,免疫发育的调节,和婴儿健康。它将有助于不断扩大的研究机构,旨在加深我们对营养之间联系的理解,肠道菌群,和早期的产后健康。
背景:澳大利亚新西兰临床试验注册中心ACTRN12620000026921;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378654。
■DERR1-10.2196/56772。
BACKGROUND: The introduction of complementary foods during the first year of life influences the diversity of the gut microbiome. How this diversity affects immune development and health is unclear.
OBJECTIVE: This study evaluates the effect of consuming kūmara or kūmara with added banana powder (resistant starch) compared to a reference control at 4 months post randomization on the prevalence of respiratory tract infections and the development of the gut microbiome.
METHODS: This study is a double-blind, randomized controlled trial of mothers and their 6-month-old infants (up to n=300) who have not yet started solids. Infants are randomized into one of 3 groups: control arm (C), standard kūmara intervention (K), and a kūmara intervention with added banana powder product (K+) to be consumed daily for 4 months until the infant is approximately 10 months old. Infants are matched for sex using stratified randomization. Data are collected at baseline (prior to commencing solid food) and at 2 and 4 months after commencing solid food (at around 8 and 10 months of age). Data and samples collected at each timepoint include weight and length, intervention adherence (months 2 and 4), illness and medication history, dietary intake (months 2 and 4), sleep (diary and actigraphy), maternal dietary intake, breast milk, feces (baseline and 4 months), and blood samples (baseline and 4 months).
RESULTS: The trial was approved by the Health and Disability Ethics Committee of the Ministry of Health, New Zealand (reference 20/NTA/9). Recruitment and data collection did not commence until January 2022 due to the COVID-19 pandemic. Data collection and analyses are expected to conclude in January 2024 and early 2025, respectively. Results are to be published in 2024 and 2025.
CONCLUSIONS: The results of this study will help us understand how the introduction of a specific prebiotic complementary food affects the microbiota and relative abundances of the microbial species, the modulation of immune development, and infant health. It will contribute to the expanding body of research that aims to deepen our understanding of the connections between nutrition, gut microbiota, and early-life postnatal health.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12620000026921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378654.
UNASSIGNED: DERR1-10.2196/56772.