滋养婴儿肠道微生物群以支持免疫健康：SUN（通过喂养播种）随机对照试验方案。

Nourishing the Infant Gut Microbiome to Support Immune Health: Protocol of SUN (Seeding Through Feeding) Randomized Controlled Trial.

机构信息

Department of Nutrition and Dietetics, University of Auckland, Auckland, New Zealand.

High-Value Nutrition, National Science Challenge, Auckland, New Zealand.

出版信息

JMIR Res Protoc. 2024 Sep 2;13:e56772. doi: 10.2196/56772.

DOI:10.2196/56772

PMID:39222346

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11406106/

Abstract

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.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12620000026921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378654.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56772.

摘要

背景

婴儿在一岁前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

本研究评估了与参考对照组相比，在随机分组后 4 个月时食用番薯或添加了香蕉粉（抗性淀粉）的番薯对呼吸道感染的发生率和肠道微生物组发育的影响。

方法

这是一项针对 6 个月大婴儿（最多 300 名）及其母亲的双盲、随机对照试验，这些婴儿尚未开始食用固体食物。婴儿被随机分为 3 组：对照组（C）、标准番薯干预组（K）和添加香蕉粉产品的番薯干预组（K+），每天食用 4 个月，直到婴儿大约 10 个月大。使用分层随机化按性别匹配婴儿。在开始食用固体食物之前（基线）和开始食用固体食物后 2 个月和 4 个月（大约 8 个月和 10 个月大时）收集数据和样本。每个时间点收集的数据和样本包括体重和身长、干预依从性（第 2 个月和第 4 个月）、疾病和用药史、饮食摄入（第 2 个月和第 4 个月）、睡眠（日记和活动记录仪）、产妇饮食摄入、母乳、粪便（基线和第 4 个月）和血液样本（基线和第 4 个月）。