The investigators have established the "Evaluating the Alimentary and Respiratory Tracts in Health and disease" (EARTH) research program. It provides a structured approach to analysing gastrointestinal and respiratory microbiomes, along with diet and symptomatology, in children with a gastrointestinal and/or respiratory condition with recognised long-term morbidity (e.g. cystic fibrosis, obstructive sleep apnoea, or Hirschsprung's disease). The EARTH program consists of a series of prospective, longitudinal, controlled, observational studies, with each individual study comparing children with a chronic gastrointestinal and/or respiratory condition to healthy controls (HC). It will be conducted in an Australian tertiary paediatric hospital (although the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared to age and gender matched HC across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) a stool sample, (ii) an oropharyngeal swab or sputum sample, (iii) a 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- and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will also be compared between children with a condition and HC. The investigators hypothesise that: (i) Children with chronic gastrointestinal and/or respiratory conditions will have altered intestinal and respiratory microbiomes compared to healthy children, and (ii) Diet plays a key role in influencing the intestinal and respiratory microbiomes and this may impact on clinical outcomes, biomarkers of disease, and health-related quality of life.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
1A.i.0 Intestinal Microbiome (Bacteria) - Richness
Timeframe: Baseline
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
Timeframe: Change from baseline at 6 months
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
Timeframe: Change from baseline at 12 months
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
Timeframe: Baseline
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
Timeframe: Change from baseline at 6 months
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
Timeframe: Change from baseline at 12 months
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Timeframe: Baseline
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Timeframe: 6 months
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Timeframe: 12 months
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Timeframe: Baseline
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Timeframe: Change from baseline at 6 months
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Timeframe: Change from baseline at 12 months
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Timeframe: Baseline
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Timeframe: Change from baseline at 6 months
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Timeframe: Change from baseline at 12 months
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Timeframe: Baseline
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Timeframe: Change from baseline at 6 months
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Timeframe: Change from baseline at 12 months
1D.i.0 Intestinal Microbiome (Viruses) - Richness
Timeframe: Baseline
1D.i.6 Intestinal Microbiome (Viruses) - Richness
Timeframe: Change from baseline at 6 months
1D.i.12 Intestinal Microbiome (Viruses) - Richness
Timeframe: Change from baseline at 12 months
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
Timeframe: Baseline
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
Timeframe: Change from baseline at 6 months
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
Timeframe: Change from baseline at 12 months
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Timeframe: Baseline
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Timeframe: 6 months
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Timeframe: 12 months
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Timeframe: Baseline
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Timeframe: Change from baseline at 6 months
1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Timeframe: Change from baseline at 12 months
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
Timeframe: Baseline
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
Timeframe: Change from baseline at 6 months
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
Timeframe: Change from baseline at 12 months
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
Timeframe: Baseline
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
Timeframe: Change from baseline at 6 months
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
Timeframe: Change from baseline at 12 months
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Timeframe: Baseline
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Timeframe: Change from baseline at 6 months
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Timeframe: Change from baseline at 12 months
2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Timeframe: Baseline
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Timeframe: Change from baseline at 6 months
2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Timeframe: Change from baseline at 12 months
2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Timeframe: Baseline
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Timeframe: Change from baseline at 6 months
2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Timeframe: Change from baseline at 12 months
2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Timeframe: Baseline
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Timeframe: Change from baseline at 6 months
2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Timeframe: Change from baseline at 12 months
2D.i.0 Respiratory Microbiome (Viruses) - Richness
Timeframe: Baseline
2D.i.6 Respiratory Microbiome (Viruses) - Richness
Timeframe: Change from baseline at 6 months
2D.i.12 Respiratory Microbiome (Viruses) - Richness
Timeframe: Change from baseline at 12 months
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
Timeframe: Baseline
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
Timeframe: Change from baseline at 6 months
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
Timeframe: Change from baseline at 12 months
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Timeframe: Baseline
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Timeframe: 6 months
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Timeframe: 12 months
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
Timeframe: Baseline
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
Timeframe: Change from baseline at 6 months
2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
Timeframe: Change from baseline at 12 months
3A.i.0 Diet - total energy intake
Timeframe: Baseline
3A.i.6 Diet - total energy intake
Timeframe: Change from baseline at 6 months
3A.i.12 Diet - total energy intake
Timeframe: Change from baseline at 12 months
3B.i.0 Diet - percentage energy from core foods
Timeframe: Baseline
3B.i.6 Diet - percentage energy from core foods
Timeframe: Change from baseline at 6 months
3B.i.12 Diet - percentage energy from core foods
Timeframe: Change from baseline at 12 months
3C.i.0 Diet - total macronutrients intake
Timeframe: Baseline
3C.i.6 Diet - total macronutrients intake
Timeframe: Change from baseline at 6 months
3C.i.12 Diet - total macronutrients intake
Timeframe: Change from baseline at 12 months
3C.ii.0 Diet - macronutrients proportion of total energy intake
Timeframe: Baseline
3C.ii.6 Diet - macronutrients proportion of total energy intake
Timeframe: Change from baseline at 6 months
3C.ii.12 Diet - macronutrients proportion of total energy intake
Timeframe: Change from baseline at 12 months
3D.i.0 Diet - total micronutrients intake
Timeframe: Baseline
3D.i.6 Diet - total micronutrients intake
Timeframe: Change from baseline at 6 months
3D.i.12 Diet - total micronutrients intake
Timeframe: Change from baseline at 12 months
3D.ii.0 Diet - micronutrients proportion of total energy intake
Timeframe: Baseline
3D.ii.6 Diet - micronutrients proportion of total energy intake
Timeframe: Change from baseline at 6 months
3D.ii.12 Diet - micronutrients proportion of total energy intake
Timeframe: Change from baseline at 12 months
3E.i.0 Diet - diet quality score
Timeframe: Baseline
3E.i.6 Diet - diet quality score
Timeframe: Change from baseline at 6 months
3E.i.12 Diet - diet quality score
Timeframe: Change from baseline at 12 months