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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04071314




Registration number
NCT04071314
Ethics application status
Date submitted
21/08/2019
Date registered
28/08/2019
Date last updated
28/08/2019

Titles & IDs
Public title
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Scientific title
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Secondary ID [1] 0 0
HREC/18/SCHN/26
Universal Trial Number (UTN)
Trial acronym
EARTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Hirschprung's Disease 0 0
Obstructive Sleep Apnea 0 0
Healthy 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cystic fibrosis - Children diagnosed with cystic fibrosis. Children aged between 0 and 18 years.

Hirschsprung's disease - Children diagnosed with Hirschsprung's disease. Children aged between 0 and 18 years.

Obstructive sleep apnoea - Children diagnosed with obstructive sleep apnoea. Children aged between 0 and 18 years.

Healthy controls - Children free of any chronic health condition. Children aged between 0 and 18 years.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1A.i.0 Intestinal Microbiome (Bacteria) - Richness
Assessment method [1] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
Assessment method [2] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [2] 0 0
Change from baseline at 6 months
Primary outcome [3] 0 0
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
Assessment method [3] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [3] 0 0
Change from baseline at 12 months
Primary outcome [4] 0 0
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
Assessment method [4] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
Assessment method [5] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [5] 0 0
Change from baseline at 6 months
Primary outcome [6] 0 0
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
Assessment method [6] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [6] 0 0
Change from baseline at 12 months
Primary outcome [7] 0 0
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Assessment method [7] 0 0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Assessment method [8] 0 0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [8] 0 0
6 months
Primary outcome [9] 0 0
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Assessment method [9] 0 0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [9] 0 0
12 months
Primary outcome [10] 0 0
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Assessment method [10] 0 0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Assessment method [11] 0 0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [11] 0 0
Change from baseline at 6 months
Primary outcome [12] 0 0
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Assessment method [12] 0 0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [12] 0 0
Change from baseline at 12 months
Primary outcome [13] 0 0
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Assessment method [13] 0 0
(assessed using LC-MS).
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Assessment method [14] 0 0
(assessed using LC-MS).
Timepoint [14] 0 0
Change from baseline at 6 months
Primary outcome [15] 0 0
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Assessment method [15] 0 0
(assessed using LC-MS).
Timepoint [15] 0 0
Change from baseline at 12 months
Primary outcome [16] 0 0
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Assessment method [16] 0 0
(assessed using LC-MS).
Timepoint [16] 0 0
Baseline
Primary outcome [17] 0 0
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Assessment method [17] 0 0
(assessed using LC-MS).
Timepoint [17] 0 0
Change from baseline at 6 months
Primary outcome [18] 0 0
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Assessment method [18] 0 0
(assessed using LC-MS).
Timepoint [18] 0 0
Change from baseline at 12 months
Primary outcome [19] 0 0
1D.i.0 Intestinal Microbiome (Viruses) - Richness
Assessment method [19] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [19] 0 0
Baseline
Primary outcome [20] 0 0
1D.i.6 Intestinal Microbiome (Viruses) - Richness
Assessment method [20] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [20] 0 0
Change from baseline at 6 months
Primary outcome [21] 0 0
1D.i.12 Intestinal Microbiome (Viruses) - Richness
Assessment method [21] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [21] 0 0
Change from baseline at 12 months
Primary outcome [22] 0 0
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
Assessment method [22] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [22] 0 0
Baseline
Primary outcome [23] 0 0
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
Assessment method [23] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [23] 0 0
Change from baseline at 6 months
Primary outcome [24] 0 0
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
Assessment method [24] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [24] 0 0
Change from baseline at 12 months
Primary outcome [25] 0 0
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Assessment method [25] 0 0
Measurement of beta diversity (assessed metagenomic sequencing).
Timepoint [25] 0 0
Baseline
Primary outcome [26] 0 0
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Assessment method [26] 0 0
Measurement of beta diversity (assessed metagenomic sequencing).
Timepoint [26] 0 0
6 months
Primary outcome [27] 0 0
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Assessment method [27] 0 0
Measurement of beta diversity (assessed metagenomic sequencing).
Timepoint [27] 0 0
12 months
Primary outcome [28] 0 0
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Assessment method [28] 0 0
ANCOM analysis (assessed metagenomic sequencing).
Timepoint [28] 0 0
Baseline
Primary outcome [29] 0 0
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Assessment method [29] 0 0
ANCOM analysis (assessed metagenomic sequencing).
Timepoint [29] 0 0
Change from baseline at 6 months
Primary outcome [30] 0 0
1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Assessment method [30] 0 0
ANCOM analysis (assessed metagenomic sequencing).
Timepoint [30] 0 0
Change from baseline at 12 months
Primary outcome [31] 0 0
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
Assessment method [31] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [31] 0 0
Baseline
Primary outcome [32] 0 0
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
Assessment method [32] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [32] 0 0
Change from baseline at 6 months
Primary outcome [33] 0 0
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
Assessment method [33] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [33] 0 0
Change from baseline at 12 months
Primary outcome [34] 0 0
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
Assessment method [34] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [34] 0 0
Baseline
Primary outcome [35] 0 0
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
Assessment method [35] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [35] 0 0
Change from baseline at 6 months
Primary outcome [36] 0 0
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
Assessment method [36] 0 0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [36] 0 0
Change from baseline at 12 months
Primary outcome [37] 0 0
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Assessment method [37] 0 0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [37] 0 0
Baseline
Primary outcome [38] 0 0
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Assessment method [38] 0 0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [38] 0 0
Change from baseline at 6 months
Primary outcome [39] 0 0
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Assessment method [39] 0 0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [39] 0 0
Change from baseline at 12 months
Primary outcome [40] 0 0
2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Assessment method [40] 0 0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [40] 0 0
Baseline
Primary outcome [41] 0 0
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Assessment method [41] 0 0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [41] 0 0
Change from baseline at 6 months
Primary outcome [42] 0 0
2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Assessment method [42] 0 0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Timepoint [42] 0 0
Change from baseline at 12 months
Primary outcome [43] 0 0
2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Assessment method [43] 0 0
(assessed using LC-MS).
Timepoint [43] 0 0
Baseline
Primary outcome [44] 0 0
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Assessment method [44] 0 0
(assessed using LC-MS).
Timepoint [44] 0 0
Change from baseline at 6 months
Primary outcome [45] 0 0
2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Assessment method [45] 0 0
(assessed using LC-MS).
Timepoint [45] 0 0
Change from baseline at 12 months
Primary outcome [46] 0 0
2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Assessment method [46] 0 0
(assessed using LC-MS).
Timepoint [46] 0 0
Baseline
Primary outcome [47] 0 0
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Assessment method [47] 0 0
(assessed using LC-MS).
Timepoint [47] 0 0
Change from baseline at 6 months
Primary outcome [48] 0 0
2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Assessment method [48] 0 0
(assessed using LC-MS).
Timepoint [48] 0 0
Change from baseline at 12 months
Primary outcome [49] 0 0
2D.i.0 Respiratory Microbiome (Viruses) - Richness
Assessment method [49] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [49] 0 0
Baseline
Primary outcome [50] 0 0
2D.i.6 Respiratory Microbiome (Viruses) - Richness
Assessment method [50] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [50] 0 0
Change from baseline at 6 months
Primary outcome [51] 0 0
2D.i.12 Respiratory Microbiome (Viruses) - Richness
Assessment method [51] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [51] 0 0
Change from baseline at 12 months
Primary outcome [52] 0 0
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
Assessment method [52] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [52] 0 0
Baseline
Primary outcome [53] 0 0
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
Assessment method [53] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [53] 0 0
Change from baseline at 6 months
Primary outcome [54] 0 0
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
Assessment method [54] 0 0
Measurement of alpha diversity (assessed metagenomic sequencing).
Timepoint [54] 0 0
Change from baseline at 12 months
Primary outcome [55] 0 0
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Assessment method [55] 0 0
Measurement of beta diversity (assessed metagenomic sequencing).
Timepoint [55] 0 0
Baseline
Primary outcome [56] 0 0
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Assessment method [56] 0 0
Measurement of beta diversity (assessed metagenomic sequencing).
Timepoint [56] 0 0
6 months
Primary outcome [57] 0 0
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Assessment method [57] 0 0
Measurement of beta diversity (assessed metagenomic sequencing).
Timepoint [57] 0 0
12 months
Primary outcome [58] 0 0
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
Assessment method [58] 0 0
ANCOM analysis (assessed metagenomic sequencing).
Timepoint [58] 0 0
Baseline
Primary outcome [59] 0 0
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
Assessment method [59] 0 0
ANCOM analysis (assessed metagenomic sequencing).
Timepoint [59] 0 0
Change from baseline at 6 months
Primary outcome [60] 0 0
2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
Assessment method [60] 0 0
ANCOM analysis (assessed metagenomic sequencing).
Timepoint [60] 0 0
Change from baseline at 12 months
Primary outcome [61] 0 0
3A.i.0 Diet - total energy intake
Assessment method [61] 0 0
Kilojoules (assessed using a 24-hour recall or ACAES).
Timepoint [61] 0 0
Baseline
Primary outcome [62] 0 0
3A.i.6 Diet - total energy intake
Assessment method [62] 0 0
Kilojoules (assessed using a 24-hour recall or ACAES).
Timepoint [62] 0 0
Change from baseline at 6 months
Primary outcome [63] 0 0
3A.i.12 Diet - total energy intake
Assessment method [63] 0 0
Kilojoules (assessed using a 24-hour recall or ACAES).
Timepoint [63] 0 0
Change from baseline at 12 months
Primary outcome [64] 0 0
3B.i.0 Diet - percentage energy from core foods
Assessment method [64] 0 0
(assessed using a 24-hour recall or ACAES).
Timepoint [64] 0 0
Baseline
Primary outcome [65] 0 0
3B.i.6 Diet - percentage energy from core foods
Assessment method [65] 0 0
(assessed using a 24-hour recall or ACAES).
Timepoint [65] 0 0
Change from baseline at 6 months
Primary outcome [66] 0 0
3B.i.12 Diet - percentage energy from core foods
Assessment method [66] 0 0
(assessed using a 24-hour recall or ACAES).
Timepoint [66] 0 0
Change from baseline at 12 months
Primary outcome [67] 0 0
3C.i.0 Diet - total macronutrients intake
Assessment method [67] 0 0
Grams (assessed using a 24-hour recall or ACAES).
Timepoint [67] 0 0
Baseline
Primary outcome [68] 0 0
3C.i.6 Diet - total macronutrients intake
Assessment method [68] 0 0
Grams (assessed using a 24-hour recall or ACAES).
Timepoint [68] 0 0
Change from baseline at 6 months
Primary outcome [69] 0 0
3C.i.12 Diet - total macronutrients intake
Assessment method [69] 0 0
Grams (assessed using a 24-hour recall or ACAES).
Timepoint [69] 0 0
Change from baseline at 12 months
Primary outcome [70] 0 0
3C.ii.0 Diet - macronutrients proportion of total energy intake
Assessment method [70] 0 0
Percentage (assessed using a 24-hour recall or ACAES).
Timepoint [70] 0 0
Baseline
Primary outcome [71] 0 0
3C.ii.6 Diet - macronutrients proportion of total energy intake
Assessment method [71] 0 0
Percentage (assessed using a 24-hour recall or ACAES).
Timepoint [71] 0 0
Change from baseline at 6 months
Primary outcome [72] 0 0
3C.ii.12 Diet - macronutrients proportion of total energy intake
Assessment method [72] 0 0
Percentage (assessed using a 24-hour recall or ACAES).
Timepoint [72] 0 0
Change from baseline at 12 months
Primary outcome [73] 0 0
3D.i.0 Diet - total micronutrients intake
Assessment method [73] 0 0
Milligrams (assessed using a 24-hour recall or ACAES).
Timepoint [73] 0 0
Baseline
Primary outcome [74] 0 0
3D.i.6 Diet - total micronutrients intake
Assessment method [74] 0 0
Milligrams (assessed using a 24-hour recall or ACAES).
Timepoint [74] 0 0
Change from baseline at 6 months
Primary outcome [75] 0 0
3D.i.12 Diet - total micronutrients intake
Assessment method [75] 0 0
Milligrams (assessed using a 24-hour recall or ACAES).
Timepoint [75] 0 0
Change from baseline at 12 months
Primary outcome [76] 0 0
3D.ii.0 Diet - micronutrients proportion of total energy intake
Assessment method [76] 0 0
Percentage (assessed using a 24-hour recall or ACAES).
Timepoint [76] 0 0
Baseline
Primary outcome [77] 0 0
3D.ii.6 Diet - micronutrients proportion of total energy intake
Assessment method [77] 0 0
Percentage (assessed using a 24-hour recall or ACAES).
Timepoint [77] 0 0
Change from baseline at 6 months
Primary outcome [78] 0 0
3D.ii.12 Diet - micronutrients proportion of total energy intake
Assessment method [78] 0 0
Percentage (assessed using a 24-hour recall or ACAES).
Timepoint [78] 0 0
Change from baseline at 12 months
Primary outcome [79] 0 0
3E.i.0 Diet - diet quality score
Assessment method [79] 0 0
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Timepoint [79] 0 0
Baseline
Primary outcome [80] 0 0
3E.i.6 Diet - diet quality score
Assessment method [80] 0 0
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Timepoint [80] 0 0
Change from baseline at 6 months
Primary outcome [81] 0 0
3E.i.12 Diet - diet quality score
Assessment method [81] 0 0
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Timepoint [81] 0 0
Change from baseline at 12 months
Secondary outcome [1] 0 0
4A.i.0 Faecal biomarkers - calprotectin
Assessment method [1] 0 0
mg/kg (assessed using an ELISA).
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
4A.i.6 Faecal biomarkers - calprotectin
Assessment method [2] 0 0
mg/kg (assessed using an ELISA).
Timepoint [2] 0 0
Change from baseline at 6 months
Secondary outcome [3] 0 0
4A.i.12 Faecal biomarkers - calprotectin
Assessment method [3] 0 0
mg/kg (assessed using an ELISA).
Timepoint [3] 0 0
Change from baseline at 12 months
Secondary outcome [4] 0 0
4A.ii.0 Faecal biomarkers - M2 pyruvate kinase
Assessment method [4] 0 0
U/mL (assessed using an ELISA).
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
4A.ii.6 Faecal biomarkers - M2 pyruvate kinase
Assessment method [5] 0 0
U/mL (assessed using an ELISA).
Timepoint [5] 0 0
Change from baseline at 6 months
Secondary outcome [6] 0 0
4A.ii.12 Faecal biomarkers - M2 pyruvate kinase
Assessment method [6] 0 0
U/mL (assessed using an ELISA).
Timepoint [6] 0 0
Change from baseline at 12 months
Secondary outcome [7] 0 0
4A.iii.0 Faecal biomarkers - C-reactive protein
Assessment method [7] 0 0
mg/L (assessed using an ELISA).
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
4A.iii.6 Faecal biomarkers - C-reactive protein
Assessment method [8] 0 0
mg/L (assessed using an ELISA).
Timepoint [8] 0 0
Change from baseline at 6 months
Secondary outcome [9] 0 0
4A.iii.12 Faecal biomarkers - C-reactive protein
Assessment method [9] 0 0
mg/L (assessed using an ELISA).
Timepoint [9] 0 0
Change from baseline at 12 months
Secondary outcome [10] 0 0
4A.iv.0 Faecal biomarkers - Interleukins
Assessment method [10] 0 0
IU (assessed using an ELISA).
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
4A.iv.6 Faecal biomarkers - Interleukins
Assessment method [11] 0 0
IU (assessed using an ELISA).
Timepoint [11] 0 0
Change from baseline at 6 months
Secondary outcome [12] 0 0
4A.iv.12 Faecal biomarkers - Interleukins
Assessment method [12] 0 0
IU (assessed using an ELISA).
Timepoint [12] 0 0
Change from baseline at 12 months
Secondary outcome [13] 0 0
4B.i.0 Respiratory biomarkers - calprotectin
Assessment method [13] 0 0
mg/kg (assessed using an ELISA).
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
4B.i.6 Respiratory biomarkers - calprotectin
Assessment method [14] 0 0
mg/kg (assessed using an ELISA).
Timepoint [14] 0 0
Change from baseline at 6 months
Secondary outcome [15] 0 0
4B.i.12 Respiratory biomarkers - calprotectin
Assessment method [15] 0 0
mg/kg (assessed using an ELISA).
Timepoint [15] 0 0
Change from baseline at 12 months
Secondary outcome [16] 0 0
4B.ii.0 Respiratory biomarkers - C-reactive protein
Assessment method [16] 0 0
mg/L (assessed using an ELISA).
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
4B.ii.6 Respiratory biomarkers - C-reactive protein
Assessment method [17] 0 0
mg/L (assessed using an ELISA).
Timepoint [17] 0 0
Change from baseline at 6 months
Secondary outcome [18] 0 0
4B.ii.12 Respiratory biomarkers - C-reactive protein
Assessment method [18] 0 0
mg/L (assessed using an ELISA).
Timepoint [18] 0 0
Change from baseline at 12 months
Secondary outcome [19] 0 0
4B.iii.0 Respiratory biomarkers - Interleukins
Assessment method [19] 0 0
IU (assessed using an ELISA).
Timepoint [19] 0 0
Baseline
Secondary outcome [20] 0 0
4B.iii.6 Respiratory biomarkers - Interleukins
Assessment method [20] 0 0
IU (assessed using an ELISA).
Timepoint [20] 0 0
Change from baseline at 6 months
Secondary outcome [21] 0 0
4B.iii.12 Respiratory biomarkers - Interleukins
Assessment method [21] 0 0
IU (assessed using an ELISA).
Timepoint [21] 0 0
Change from baseline at 12 months
Secondary outcome [22] 0 0
5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Assessment method [22] 0 0
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Timepoint [22] 0 0
Baseline
Secondary outcome [23] 0 0
5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Assessment method [23] 0 0
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Timepoint [23] 0 0
Change from baseline at 6 months
Secondary outcome [24] 0 0
5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Assessment method [24] 0 0
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Timepoint [24] 0 0
Change from baseline at 12 months
Secondary outcome [25] 0 0
5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Assessment method [25] 0 0
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Assessment method [26] 0 0
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [26] 0 0
Change from baseline at 6 months
Secondary outcome [27] 0 0
5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Assessment method [27] 0 0
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [27] 0 0
Change from baseline at 12 months
Secondary outcome [28] 0 0
5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Assessment method [28] 0 0
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.
Timepoint [28] 0 0
Baseline
Secondary outcome [29] 0 0
5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Assessment method [29] 0 0
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.
Timepoint [29] 0 0
Change from baseline at 6 months
Secondary outcome [30] 0 0
5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Assessment method [30] 0 0
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.
Timepoint [30] 0 0
Change from baseline at 12 months
Secondary outcome [31] 0 0
5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Assessment method [31] 0 0
Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [31] 0 0
Baseline
Secondary outcome [32] 0 0
5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Assessment method [32] 0 0
Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [32] 0 0
Change from baseline at 6 months
Secondary outcome [33] 0 0
5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Assessment method [33] 0 0
Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [33] 0 0
Change from baseline at 12 months
Secondary outcome [34] 0 0
5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Assessment method [34] 0 0
Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [34] 0 0
Baseline
Secondary outcome [35] 0 0
5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Assessment method [35] 0 0
Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [35] 0 0
Change from baseline at 6 months
Secondary outcome [36] 0 0
5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Assessment method [36] 0 0
Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
Timepoint [36] 0 0
Change from baseline at 12 months
Secondary outcome [37] 0 0
5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Assessment method [37] 0 0
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.
Timepoint [37] 0 0
Baseline
Secondary outcome [38] 0 0
5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Assessment method [38] 0 0
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.
Timepoint [38] 0 0
6 months
Secondary outcome [39] 0 0
5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Assessment method [39] 0 0
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.
Timepoint [39] 0 0
12 months
Secondary outcome [40] 0 0
5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
Assessment method [40] 0 0
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.
Timepoint [40] 0 0
Baseline
Secondary outcome [41] 0 0
5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
Assessment method [41] 0 0
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.
Timepoint [41] 0 0
6 months
Secondary outcome [42] 0 0
5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
Assessment method [42] 0 0
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.
Timepoint [42] 0 0
12 months
Secondary outcome [43] 0 0
5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
Assessment method [43] 0 0
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.
Timepoint [43] 0 0
Baseline
Secondary outcome [44] 0 0
5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
Assessment method [44] 0 0
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.
Timepoint [44] 0 0
6 months
Secondary outcome [45] 0 0
5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
Assessment method [45] 0 0
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.
Timepoint [45] 0 0
12 months
Secondary outcome [46] 0 0
5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
Assessment method [46] 0 0
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.
Timepoint [46] 0 0
Baseline
Secondary outcome [47] 0 0
5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
Assessment method [47] 0 0
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.
Timepoint [47] 0 0
Change from baseline at 6 months
Secondary outcome [48] 0 0
5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
Assessment method [48] 0 0
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.
Timepoint [48] 0 0
Change from baseline at 12 months
Secondary outcome [49] 0 0
5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Assessment method [49] 0 0
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.
Timepoint [49] 0 0
Baseline
Secondary outcome [50] 0 0
5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Assessment method [50] 0 0
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.
Timepoint [50] 0 0
Change from baseline at 6 months
Secondary outcome [51] 0 0
5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Assessment method [51] 0 0
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.
Timepoint [51] 0 0
Change from baseline at 12 months
Secondary outcome [52] 0 0
5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Assessment method [52] 0 0
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.
Timepoint [52] 0 0
Baseline
Secondary outcome [53] 0 0
5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Assessment method [53] 0 0
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.
Timepoint [53] 0 0
Change from baseline at 6 months
Secondary outcome [54] 0 0
5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Assessment method [54] 0 0
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.
Timepoint [54] 0 0
Change from baseline at 12 months
Secondary outcome [55] 0 0
5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Assessment method [55] 0 0
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.
Timepoint [55] 0 0
Baseline
Secondary outcome [56] 0 0
5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Assessment method [56] 0 0
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.
Timepoint [56] 0 0
Change from baseline at 6 months
Secondary outcome [57] 0 0
5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Assessment method [57] 0 0
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.
Timepoint [57] 0 0
Change from baseline at 12 months
Secondary outcome [58] 0 0
5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Assessment method [58] 0 0
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.
Timepoint [58] 0 0
Baseline
Secondary outcome [59] 0 0
5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Assessment method [59] 0 0
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.
Timepoint [59] 0 0
Change from baseline at 6 months
Secondary outcome [60] 0 0
5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Assessment method [60] 0 0
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.
Timepoint [60] 0 0
Change from baseline at 12 months
Secondary outcome [61] 0 0
6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Assessment method [61] 0 0
Z-score.
Timepoint [61] 0 0
Baseline
Secondary outcome [62] 0 0
6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Assessment method [62] 0 0
Z-score.
Timepoint [62] 0 0
Change from baseline at 6 months
Secondary outcome [63] 0 0
6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Assessment method [63] 0 0
Z-score.
Timepoint [63] 0 0
Change from baseline at 12 months
Secondary outcome [64] 0 0
6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Assessment method [64] 0 0
Z-score.
Timepoint [64] 0 0
Baseline
Secondary outcome [65] 0 0
6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Assessment method [65] 0 0
Z-score.
Timepoint [65] 0 0
Change from baseline at 6 months
Secondary outcome [66] 0 0
6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Assessment method [66] 0 0
Z-score.
Timepoint [66] 0 0
Change from baseline at 12 months
Secondary outcome [67] 0 0
6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Assessment method [67] 0 0
Z-score.
Timepoint [67] 0 0
Baseline
Secondary outcome [68] 0 0
6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Assessment method [68] 0 0
Z-score.
Timepoint [68] 0 0
Change from baseline at 6 months
Secondary outcome [69] 0 0
6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Assessment method [69] 0 0
Z-score.
Timepoint [69] 0 0
Change from baseline at 12 months
Secondary outcome [70] 0 0
6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Assessment method [70] 0 0
Z-score.
Timepoint [70] 0 0
Baseline
Secondary outcome [71] 0 0
6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Assessment method [71] 0 0
Z-score.
Timepoint [71] 0 0
Change from baseline at 6 months
Secondary outcome [72] 0 0
6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Assessment method [72] 0 0
Z-score.
Timepoint [72] 0 0
Change from baseline at 12 months
Secondary outcome [73] 0 0
6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Assessment method [73] 0 0
Z-score.
Timepoint [73] 0 0
Baseline
Secondary outcome [74] 0 0
6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Assessment method [74] 0 0
Z-score.
Timepoint [74] 0 0
Change from baseline at 6 months
Secondary outcome [75] 0 0
6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Assessment method [75] 0 0
Z-score.
Timepoint [75] 0 0
Change from baseline at 12 months
Secondary outcome [76] 0 0
6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
Assessment method [76] 0 0
During period from baseline to 6 months.
Timepoint [76] 0 0
6 months
Secondary outcome [77] 0 0
6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
Assessment method [77] 0 0
During period from baseline to 12 months.
Timepoint [77] 0 0
12 months
Secondary outcome [78] 0 0
6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
Assessment method [78] 0 0
Days hospitalised during period from baseline to 6 months.
Timepoint [78] 0 0
6 months
Secondary outcome [79] 0 0
6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
Assessment method [79] 0 0
Days hospitalised during period from baseline to 12 months.
Timepoint [79] 0 0
12 months
Secondary outcome [80] 0 0
6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
Assessment method [80] 0 0
During period from baseline to 6 months.
Timepoint [80] 0 0
6 months
Secondary outcome [81] 0 0
6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
Assessment method [81] 0 0
During period from baseline to 12 months.
Timepoint [81] 0 0
12 months

Eligibility
Key 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.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/03/2023
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Coffey
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Coffey
Address 0 0
Country 0 0
Phone 0 0
61293825574
Email 0 0
michael.coffey@unsw.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04071314