Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
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.
The objective of this research program is to evaluate and compare children with a chronic
 gastrointestinal and/or respiratory condition and age and gender matched HC. The primary
 objectives include analysing the intestinal and respiratory microbiomes (using an integrated
 "omics" approach) and dietary intake using validated, food frequency quetsionnaires. The
 secondary objectives include evaluating:

 1. Known inflammatory biomarkers.

 2. Symptomatology and health-related quality of life (HRQOL) using validated measures.

 3. Phenotypic and clinical information.

 4. Sociodemographic factors Additional secondary objectives include correlating within
 children with the same condition: (i) dietary intake with the intestinal microbiome;
 (ii) dietary intake with the respiratory microbiome; and (iii) the intestinal and
 respiratory microbiomes.

 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.

 To our knowledge, this program will enable the first series of studies comparing the
 intestinal and respiratory microbiomes and diet in children with chronic gastrointestinal
 and/or respiratory conditions. Initial results will be hypothesis-generating and used to
 direct future studies tailored to a specific focus or line of inquiry. Additionally, studies
 from this research program have potential for direct translation into clinical care as diet
 is a highly modifiable factor.

 Study design. The EARTH program provides a framework for a series of prospective,
 longitudinal, controlled, observational studies, with each individual study comparing
 children with a chronic gastrointestinal and/or respiratory condition to HC. A single healthy
 control group will be used for comparison against all conditions. The standardised
 methodological approach will also allow for comparisons between different health conditions.

 Procedures.

 Each participant will be assessed on three occasions over a 12-month period; at study entry,
 6- and 12-month follow-up. At each time-point, the following will be collected:

 -  A stool sample;

 -  An oropharyngeal swab or sputum sample (a sputum sample will be obtained in children
 able to expectorate and an oropharyngeal swab will be collected in children unable to
 expectorate);

 -  Dietary intake measured using the Australian Child and Adolescent Eating Survey (ACAES)
 (2 to 18 years) or 24-hour food recall (0 up to 2 years);

 -  A secure, password-protected online survey comprising:

 i. PedsQL Infant Scales (0-2yr) & Gastrointestinal Symptoms Module (2-18yr),41-43
 tailored to age; ii. Rome IV Questionnaire (0 to 18 years); iii. Spence Children's
 Anxiety Scale (3 to 18 years); iv. Short Mood and Feelings Questionnaires (6 to 18
 years); v. Clinical and biochemical results obtained through routine care and
 hospitalisations (if available); vi. Sociodemographic factors (baseline survey only);

 -  Anthropometrics: height, weight and BMI z-scores.
Inclusion Criteria:

 -  Are aged between 0 and 18 years;

 -  Have been diagnosed with a chronic gastrointestinal and/or respiratory condition
 defined by consensus diagnostic criteria; or

 -  Are free of any chronic health condition (healthy control group); and

 -  Have a parent(s)/carer(s) who provides informed consent, or are at least 16 years old
 and provide informed consent.

 Exclusion Criteria:

 -  Children who have an unrelated coexisting chronic medical illness(es) associated with
 alterations in dietary intake or suspected alterations in the intestinal and/or
 respiratory microbiomes;

 -  Inability to comply with study requirements;

 -  Parent(s)/guardian(s) are unable to speak English or do not have a reading level age
 of at least 12 years.