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.
Study Type
OBSERVATIONAL
Enrollment
72
Sydney Children's Hospital
Randwick, New South Wales, Australia
RECRUITING1A.i.0 Intestinal Microbiome (Bacteria) - Richness
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: 6 months
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: 12 months
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
(assessed using LC-MS).
Time frame: Baseline
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
(assessed using LC-MS).
Time frame: Change from baseline at 6 months
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
(assessed using LC-MS).
Time frame: Change from baseline at 12 months
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
(assessed using LC-MS).
Time frame: Baseline
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
(assessed using LC-MS).
Time frame: Change from baseline at 6 months
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
(assessed using LC-MS).
Time frame: Change from baseline at 12 months
1D.i.0 Intestinal Microbiome (Viruses) - Richness
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Baseline
1D.i.6 Intestinal Microbiome (Viruses) - Richness
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 6 months
1D.i.12 Intestinal Microbiome (Viruses) - Richness
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 12 months
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Baseline
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 6 months
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 12 months
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Measurement of beta diversity (assessed metagenomic sequencing).
Time frame: Baseline
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Measurement of beta diversity (assessed metagenomic sequencing).
Time frame: 6 months
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Measurement of beta diversity (assessed metagenomic sequencing).
Time frame: 12 months
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
ANCOM analysis (assessed metagenomic sequencing).
Time frame: Baseline
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
ANCOM analysis (assessed metagenomic sequencing).
Time frame: Change from baseline at 6 months
1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
ANCOM analysis (assessed metagenomic sequencing).
Time frame: Change from baseline at 12 months
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Baseline
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 6 months
2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Time frame: Change from baseline at 12 months
2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
(assessed using LC-MS).
Time frame: Baseline
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
(assessed using LC-MS).
Time frame: Change from baseline at 6 months
2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
(assessed using LC-MS).
Time frame: Change from baseline at 12 months
2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
(assessed using LC-MS).
Time frame: Baseline
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
(assessed using LC-MS).
Time frame: Change from baseline at 6 months
2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
(assessed using LC-MS).
Time frame: Change from baseline at 12 months
2D.i.0 Respiratory Microbiome (Viruses) - Richness
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Baseline
2D.i.6 Respiratory Microbiome (Viruses) - Richness
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 6 months
2D.i.12 Respiratory Microbiome (Viruses) - Richness
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 12 months
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Baseline
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 6 months
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
Measurement of alpha diversity (assessed metagenomic sequencing).
Time frame: Change from baseline at 12 months
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Measurement of beta diversity (assessed metagenomic sequencing).
Time frame: Baseline
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Measurement of beta diversity (assessed metagenomic sequencing).
Time frame: 6 months
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Measurement of beta diversity (assessed metagenomic sequencing).
Time frame: 12 months
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
ANCOM analysis (assessed metagenomic sequencing).
Time frame: Baseline
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
ANCOM analysis (assessed metagenomic sequencing).
Time frame: Change from baseline at 6 months
2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
ANCOM analysis (assessed metagenomic sequencing).
Time frame: Change from baseline at 12 months
3A.i.0 Diet - total energy intake
Kilojoules (assessed using a 24-hour recall or ACAES).
Time frame: Baseline
3A.i.6 Diet - total energy intake
Kilojoules (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 6 months
3A.i.12 Diet - total energy intake
Kilojoules (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 12 months
3B.i.0 Diet - percentage energy from core foods
(assessed using a 24-hour recall or ACAES).
Time frame: Baseline
3B.i.6 Diet - percentage energy from core foods
(assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 6 months
3B.i.12 Diet - percentage energy from core foods
(assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 12 months
3C.i.0 Diet - total macronutrients intake
Grams (assessed using a 24-hour recall or ACAES).
Time frame: Baseline
3C.i.6 Diet - total macronutrients intake
Grams (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 6 months
3C.i.12 Diet - total macronutrients intake
Grams (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 12 months
3C.ii.0 Diet - macronutrients proportion of total energy intake
Percentage (assessed using a 24-hour recall or ACAES).
Time frame: Baseline
3C.ii.6 Diet - macronutrients proportion of total energy intake
Percentage (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 6 months
3C.ii.12 Diet - macronutrients proportion of total energy intake
Percentage (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 12 months
3D.i.0 Diet - total micronutrients intake
Milligrams (assessed using a 24-hour recall or ACAES).
Time frame: Baseline
3D.i.6 Diet - total micronutrients intake
Milligrams (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 6 months
3D.i.12 Diet - total micronutrients intake
Milligrams (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 12 months
3D.ii.0 Diet - micronutrients proportion of total energy intake
Percentage (assessed using a 24-hour recall or ACAES).
Time frame: Baseline
3D.ii.6 Diet - micronutrients proportion of total energy intake
Percentage (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 6 months
3D.ii.12 Diet - micronutrients proportion of total energy intake
Percentage (assessed using a 24-hour recall or ACAES).
Time frame: Change from baseline at 12 months
3E.i.0 Diet - diet quality score
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Time frame: Baseline
3E.i.6 Diet - diet quality score
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Time frame: Change from baseline at 6 months
3E.i.12 Diet - diet quality score
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Time frame: Change from baseline at 12 months
4A.i.0 Faecal biomarkers - calprotectin
mg/kg (assessed using an ELISA).
Time frame: Baseline
4A.i.6 Faecal biomarkers - calprotectin
mg/kg (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4A.i.12 Faecal biomarkers - calprotectin
mg/kg (assessed using an ELISA).
Time frame: Change from baseline at 12 months
4A.ii.0 Faecal biomarkers - M2 pyruvate kinase
U/mL (assessed using an ELISA).
Time frame: Baseline
4A.ii.6 Faecal biomarkers - M2 pyruvate kinase
U/mL (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4A.ii.12 Faecal biomarkers - M2 pyruvate kinase
U/mL (assessed using an ELISA).
Time frame: Change from baseline at 12 months
4A.iii.0 Faecal biomarkers - C-reactive protein
mg/L (assessed using an ELISA).
Time frame: Baseline
4A.iii.6 Faecal biomarkers - C-reactive protein
mg/L (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4A.iii.12 Faecal biomarkers - C-reactive protein
mg/L (assessed using an ELISA).
Time frame: Change from baseline at 12 months
4A.iv.0 Faecal biomarkers - Interleukins
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IU (assessed using an ELISA).
Time frame: Baseline
4A.iv.6 Faecal biomarkers - Interleukins
IU (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4A.iv.12 Faecal biomarkers - Interleukins
IU (assessed using an ELISA).
Time frame: Change from baseline at 12 months
4B.i.0 Respiratory biomarkers - calprotectin
mg/kg (assessed using an ELISA).
Time frame: Baseline
4B.i.6 Respiratory biomarkers - calprotectin
mg/kg (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4B.i.12 Respiratory biomarkers - calprotectin
mg/kg (assessed using an ELISA).
Time frame: Change from baseline at 12 months
4B.ii.0 Respiratory biomarkers - C-reactive protein
mg/L (assessed using an ELISA).
Time frame: Baseline
4B.ii.6 Respiratory biomarkers - C-reactive protein
mg/L (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4B.ii.12 Respiratory biomarkers - C-reactive protein
mg/L (assessed using an ELISA).
Time frame: Change from baseline at 12 months
4B.iii.0 Respiratory biomarkers - Interleukins
IU (assessed using an ELISA).
Time frame: Baseline
4B.iii.6 Respiratory biomarkers - Interleukins
IU (assessed using an ELISA).
Time frame: Change from baseline at 6 months
4B.iii.12 Respiratory biomarkers - Interleukins
IU (assessed using an ELISA).
Time frame: Change from baseline at 12 months
5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Time frame: Baseline
5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 6 months
5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 12 months
5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Baseline
5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 6 months
5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 12 months
5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Parent report for young children (ages 5-7 years) or young child report (ages 5-7 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Baseline
5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Parent report for young children (ages 5-7 years) or young child report (ages 5-7 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 6 months
5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Parent report for young children (ages 5-7 years) or young child report (ages 5-7 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 12 months
5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Baseline
5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 6 months
5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 12 months
5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Baseline
5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 6 months
5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
Time frame: Change from baseline at 12 months
5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
29 items for ages 0-12 months. 18 items for ages 1-3 years. Defined diagnostic criteria for functional gastrointestinal disorders in neonates and toddlers: Infant regurgitation, Infant rumination syndrome, Cyclic vomiting syndrome, Infant colic, Functional diarrhoea, Infant dyschezia, Functional constipation.
Time frame: Baseline
5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
29 items for ages 0-12 months. 18 items for ages 1-3 years. Defined diagnostic criteria for functional gastrointestinal disorders in neonates and toddlers: Infant regurgitation, Infant rumination syndrome, Cyclic vomiting syndrome, Infant colic, Functional diarrhoea, Infant dyschezia, Functional constipation.
Time frame: 6 months
5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
29 items for ages 0-12 months. 18 items for ages 1-3 years. Defined diagnostic criteria for functional gastrointestinal disorders in neonates and toddlers: Infant regurgitation, Infant rumination syndrome, Cyclic vomiting syndrome, Infant colic, Functional diarrhoea, Infant dyschezia, Functional constipation.
Time frame: 12 months
5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
42 items. Defined diagnostic criteria for functional gastrointestinal disorders in children and adolescents: Cyclic vomiting syndrome, Functional nausea and functional vomiting, Rumination syndrome, Aerophagia, Functional dyspepsia, Irritable bowel syndrome, Abdominal migraine, Functional abdominal pain - not otherwise specified, Functional Constipation, Nonretentive fecal incontinence.
Time frame: Baseline
5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
42 items. Defined diagnostic criteria for functional gastrointestinal disorders in children and adolescents: Cyclic vomiting syndrome, Functional nausea and functional vomiting, Rumination syndrome, Aerophagia, Functional dyspepsia, Irritable bowel syndrome, Abdominal migraine, Functional abdominal pain - not otherwise specified, Functional Constipation, Nonretentive fecal incontinence.
Time frame: 6 months
5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
42 items. Defined diagnostic criteria for functional gastrointestinal disorders in children and adolescents: Cyclic vomiting syndrome, Functional nausea and functional vomiting, Rumination syndrome, Aerophagia, Functional dyspepsia, Irritable bowel syndrome, Abdominal migraine, Functional abdominal pain - not otherwise specified, Functional Constipation, Nonretentive fecal incontinence.
Time frame: 12 months
5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
42 items. Defined diagnostic criteria for functional gastrointestinal disorders in children and adolescents: Cyclic vomiting syndrome, Functional nausea and functional vomiting, Rumination syndrome, Aerophagia, Functional dyspepsia, Irritable bowel syndrome, Abdominal migraine, Functional abdominal pain - not otherwise specified, Functional Constipation, Nonretentive fecal incontinence.
Time frame: Baseline
5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
42 items. Defined diagnostic criteria for functional gastrointestinal disorders in children and adolescents: Cyclic vomiting syndrome, Functional nausea and functional vomiting, Rumination syndrome, Aerophagia, Functional dyspepsia, Irritable bowel syndrome, Abdominal migraine, Functional abdominal pain - not otherwise specified, Functional Constipation, Nonretentive fecal incontinence.
Time frame: 6 months
5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
42 items. Defined diagnostic criteria for functional gastrointestinal disorders in children and adolescents: Cyclic vomiting syndrome, Functional nausea and functional vomiting, Rumination syndrome, Aerophagia, Functional dyspepsia, Irritable bowel syndrome, Abdominal migraine, Functional abdominal pain - not otherwise specified, Functional Constipation, Nonretentive fecal incontinence.
Time frame: 12 months
5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
34 items. Maximum possible scores of 112. A score 1 SD above mean for a subscale or total score warrants further clinical investigation. A score of 0.5 SD above the mean on total score is indicative of an elevated, but not clinical level of anxiety.
Time frame: Baseline
5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
34 items. Maximum possible scores of 112. A score 1 SD above mean for a subscale or total score warrants further clinical investigation. A score of 0.5 SD above the mean on total score is indicative of an elevated, but not clinical level of anxiety.
Time frame: Change from baseline at 6 months
5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
34 items. Maximum possible scores of 112. A score 1 SD above mean for a subscale or total score warrants further clinical investigation. A score of 0.5 SD above the mean on total score is indicative of an elevated, but not clinical level of anxiety.
Time frame: Change from baseline at 12 months
5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
38 scored items. Maximum possible scores of 114. A score 1 SD above mean (T-score of ≥ 60) for a subscale or total score is indicative of subclinical or elevated levels of anxiety warranting further clinical investigation.
Time frame: Baseline
5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
38 scored items. Maximum possible scores of 114. A score 1 SD above mean (T-score of ≥ 60) for a subscale or total score is indicative of subclinical or elevated levels of anxiety warranting further clinical investigation.
Time frame: Change from baseline at 6 months
5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
38 scored items. Maximum possible scores of 114. A score 1 SD above mean (T-score of ≥ 60) for a subscale or total score is indicative of subclinical or elevated levels of anxiety warranting further clinical investigation.
Time frame: Change from baseline at 12 months
5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
38 scored items. Maximum possible scores of 114. A score 1 SD above mean (T-score of ≥ 60) for a subscale or total score is indicative of subclinical or elevated levels of anxiety warranting further clinical investigation.
Time frame: Baseline
5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
38 scored items. Maximum possible scores of 114. A score 1 SD above mean (T-score of ≥ 60) for a subscale or total score is indicative of subclinical or elevated levels of anxiety warranting further clinical investigation.
Time frame: Change from baseline at 6 months
5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
38 scored items. Maximum possible scores of 114. A score 1 SD above mean (T-score of ≥ 60) for a subscale or total score is indicative of subclinical or elevated levels of anxiety warranting further clinical investigation.
Time frame: Change from baseline at 12 months
5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
13 items. Maximum possible scores of 26. Higher scores suggest more severe depressive symptoms. A score of ≥ 12 may indicate the presence of depression in the respondent.
Time frame: Baseline
5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
13 items. Maximum possible scores of 26. Higher scores suggest more severe depressive symptoms. A score of ≥ 12 may indicate the presence of depression in the respondent.
Time frame: Change from baseline at 6 months
5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
13 items. Maximum possible scores of 26. Higher scores suggest more severe depressive symptoms. A score of ≥ 12 may indicate the presence of depression in the respondent.
Time frame: Change from baseline at 12 months
5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
13 items. Maximum possible scores of 26. Higher scores suggest more severe depressive symptoms. A score of ≥ 12 may indicate the presence of depression in the respondent.
Time frame: Baseline
5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
13 items. Maximum possible scores of 26. Higher scores suggest more severe depressive symptoms. A score of ≥ 12 may indicate the presence of depression in the respondent.
Time frame: Change from baseline at 6 months
5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
13 items. Maximum possible scores of 26. Higher scores suggest more severe depressive symptoms. A score of ≥ 12 may indicate the presence of depression in the respondent.
Time frame: Change from baseline at 12 months
6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Z-score.
Time frame: Baseline
6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Z-score.
Time frame: Change from baseline at 6 months
6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Z-score.
Time frame: Change from baseline at 12 months
6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Z-score.
Time frame: Baseline
6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Z-score.
Time frame: Change from baseline at 6 months
6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Z-score.
Time frame: Change from baseline at 12 months
6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Z-score.
Time frame: Baseline
6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Z-score.
Time frame: Change from baseline at 6 months
6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Z-score.
Time frame: Change from baseline at 12 months
6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Z-score.
Time frame: Baseline
6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Z-score.
Time frame: Change from baseline at 6 months
6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Z-score.
Time frame: Change from baseline at 12 months
6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Z-score.
Time frame: Baseline
6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Z-score.
Time frame: Change from baseline at 6 months
6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Z-score.
Time frame: Change from baseline at 12 months
6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
During period from baseline to 6 months.
Time frame: 6 months
6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
During period from baseline to 12 months.
Time frame: 12 months
6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
Days hospitalised during period from baseline to 6 months.
Time frame: 6 months
6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
Days hospitalised during period from baseline to 12 months.
Time frame: 12 months
6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
During period from baseline to 6 months.
Time frame: 6 months
6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
During period from baseline to 12 months.
Time frame: 12 months