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评估健康和疾病中的消化道和呼吸道(EARTH)研究计划:一项针对澳大利亚一家三级儿科医院患有慢性疾病的儿童进行前瞻性、纵向、对照、观察性研究的方案。

Evaluating the Alimentary and Respiratory Tracts in Health and disease (EARTH) research programme: a protocol for prospective, longitudinal, controlled, observational studies in children with chronic disease at an Australian tertiary paediatric hospital.

机构信息

Discipline of Paediatrics, School of Women's and Children's Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Department of Physiotherapy, Sydney Children's Hospital Randwick, Sydney, New South Wales, Australia.

出版信息

BMJ Open. 2020 Apr 14;10(4):e033916. doi: 10.1136/bmjopen-2019-033916.

DOI:10.1136/bmjopen-2019-033916
PMID:32295774
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7200033/
Abstract

INTRODUCTION

Chronic gastrointestinal and respiratory conditions of childhood can have long-lasting physical, psychosocial and economic effects on children and their families. Alterations in diet and intestinal and respiratory microbiomes may have important implications for physical and psychosocial health. Diet influences the intestinal microbiome and should be considered when exploring disease-specific alterations. The concepts of gut-brain and gut-lung axes provide novel perspectives for examining chronic childhood disease(s). We established the 'valuating the limentary and espiratory racts in ealth and disease' (EARTH) research programme to provide a structured, holistic evaluation of children with chronic gastrointestinal and/or respiratory conditions.

METHODS AND ANALYSIS

The EARTH programme provides a framework for a series of prospective, longitudinal, controlled, observational studies (comprised of individual substudies), conducted at an Australian tertiary paediatric hospital (the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared with age and gender matched healthy controls (HC) across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) stool, (ii) oropharyngeal swab/sputum, (iii) semi-quantitative food frequency questionnaire, (iv) details of disease symptomatology, (v) health-related quality of life and (vi) psychosocial factors. Data on the intestinal and respiratory microbiomes and diet will be compared between children with a condition and HC. Correlations between dietary intake (energy, macro-nutrients and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will be compared between condition and HC cohorts.Results will be hypothesis-generating and direct future focussed studies. There is future potential for direct translation into clinical care, as diet is a highly modifiable factor.

ETHICS AND DISSEMINATION

Ethics approval: Sydney Children's Hospitals Network Human Research Ethics Committee (HREC/18/SCHN/26). Results will be presented at international conferences and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT04071314.

摘要

简介

儿童慢性胃肠道和呼吸道疾病会对儿童及其家庭的身体、心理社会和经济产生长期影响。饮食和肠道及呼吸道微生物组的改变可能对身体和心理社会健康有重要影响。饮食会影响肠道微生物组,因此在探索特定疾病的改变时应予以考虑。“肠-脑”和“肠-肺”轴的概念为研究慢性儿童疾病提供了新的视角。我们建立了“评估胃肠道和呼吸道在健康和疾病中的作用”(EARTH)研究项目,以对患有慢性胃肠道和/或呼吸道疾病的儿童进行系统、全面的评估。

方法和分析

EARTH 项目为一系列前瞻性、纵向、对照、观察性研究(由多个子研究组成)提供了一个框架,这些研究在澳大利亚一家三级儿科医院进行(该方法适用于其他环境)。患有慢性胃肠道和/或呼吸道疾病的儿童将在 12 个月内与年龄和性别匹配的健康对照(HC)进行比较。将在基线、6 个月和 12 个月时收集以下内容:(i)粪便,(ii)口咽拭子/痰,(iii)半定量食物频率问卷,(iv)疾病症状的详细信息,(v)健康相关生活质量和(vi)心理社会因素。将比较患有疾病的儿童和 HC 之间的肠道和呼吸道微生物组和饮食。将在每个组内探索饮食摄入(能量、宏量营养素和微量营养素)、肠道和呼吸道微生物组之间的相关性。将比较疾病症状、生活质量和心理社会因素在疾病和 HC 队列之间的差异。结果将是产生假说,并直接为未来的研究提供重点。由于饮食是一个高度可改变的因素,因此未来有可能直接转化为临床护理。

伦理和传播

伦理批准:悉尼儿童医院网络人体研究伦理委员会(HREC/18/SCHN/26)。结果将在国际会议上公布,并发表在同行评议的期刊上。

试验注册编号

NCT04071314。

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