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

Abstract

IntroductionChronic 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 ‘Evaluating theAlimentary andRespiratoryTracts inHealth and disease’ (EARTH) research programme to provide a structured, holistic evaluation of children with chronic gastrointestinal and/or respiratory conditions.Methods and analysisThe 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 disseminationEthics 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 numberNCT04071314

Intestinal dysbiosis and inflammation in children with repaired esophageal atresia

“…The subjects and samples for this analysis were collected as part of the EARTH (Evaluating the Alimentary and Respiratory Tracts in Health and Disease) Research Program. 13…”

Diet and the gut-lung axis in cystic fibrosis – direct & indirect links

“…The study forms part of the EARTH ( E valuating the A limentary and R espiratory T racts in H ealth and disease) program (ethical approval HREC/18/SCHN/26), described in detail in the previously published protocol. 29 The study was a single-center study conducted at an Australian tertiary pediatric hospital – the Sydney Children’s Hospital (SCH) in Randwick, Australia – from April 2018 to September 2019. Inclusion criteria were as follows: i) aged between 0 and 18 years; ii) diagnosed with CF according to the Cystic Fibrosis Foundation consensus criteria 30 (CF group) or free of any chronic health condition (HC group); and iii) provided informed consent if 16 years of age or older or a parent(s)/carer(s) provided informed consent on their behalf.…”

“…All subjects were requested to provide a stool and an airway (sputum or oropharyngeal swab if non-productive) sample, collected as per the EARTH program protocol. 29 Stool and airway samples underwent DNA extraction and 16S ribosomal RNA gene sequencing. DNA was extracted using the QIAamp Fast DNA Stool Mini Kit and QIAamp DNA Mini Kit (QIAGEN, Hilden, Germany) for stool and airway samples, respectively, according to the manufacturer’s instructions.…”

“…Dietary intakes were quantified by the Australian Child and Adolescent Eating Survey (ACAES), a 120-item semi-quantitative food frequency questionnaire measuring intakes over the preceding 6 months (validated for Australian participants aged 2 years or older) (University of Newcastle, Australia) 32 according to the methods outlined in the EARTH protocol. 29 Children under 2 years of age underwent a dietitian-administered 24-hour food recall, measuring intakes over the preceding day. Nutrient intake data from the recalls was extracted using FoodWorks (v9) and the following databases: AusFoods 2017 and AusBrands 2017 (Xyris Software, Australia).…”

Evaluating the Dietary Intake of Children With Esophageal Atresia: A Prospective, Controlled, Observational Study

“…A cross‐sectional cohort study in children with EA and HC was undertaken at Sydney Children's Hospital (SCH), Randwick, Australia. Participants were recruited, and data were collected between February 2018 and August 2019 as part of the Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program (20).…”