Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
Timepoint [2] 0 0
Change from baseline at 6 months
Primary outcome [3] 0 0
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
Timepoint [3] 0 0
Change from baseline at 12 months
Primary outcome [4] 0 0
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
Timepoint [5] 0 0
Change from baseline at 6 months
Primary outcome [6] 0 0
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
Timepoint [6] 0 0
Change from baseline at 12 months
Primary outcome [7] 0 0
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Timepoint [8] 0 0
6 months
Primary outcome [9] 0 0
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Timepoint [9] 0 0
12 months
Primary outcome [10] 0 0
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
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
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
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
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
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
Timepoint [16] 0 0
Baseline
Primary outcome [17] 0 0
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
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
Timepoint [18] 0 0
Change from baseline at 12 months
Primary outcome [19] 0 0
1D.i.0 Intestinal Microbiome (Viruses) - Richness
Timepoint [19] 0 0
Baseline
Primary outcome [20] 0 0
1D.i.6 Intestinal Microbiome (Viruses) - Richness
Timepoint [20] 0 0
Change from baseline at 6 months
Primary outcome [21] 0 0
1D.i.12 Intestinal Microbiome (Viruses) - Richness
Timepoint [21] 0 0
Change from baseline at 12 months
Primary outcome [22] 0 0
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
Timepoint [22] 0 0
Baseline
Primary outcome [23] 0 0
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
Timepoint [23] 0 0
Change from baseline at 6 months
Primary outcome [24] 0 0
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
Timepoint [24] 0 0
Change from baseline at 12 months
Primary outcome [25] 0 0
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Timepoint [25] 0 0
Baseline
Primary outcome [26] 0 0
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Timepoint [26] 0 0
6 months
Primary outcome [27] 0 0
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Timepoint [27] 0 0
12 months
Primary outcome [28] 0 0
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Timepoint [28] 0 0
Baseline
Primary outcome [29] 0 0
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
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.
Timepoint [30] 0 0
Change from baseline at 12 months
Primary outcome [31] 0 0
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
Timepoint [31] 0 0
Baseline
Primary outcome [32] 0 0
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
Timepoint [32] 0 0
Change from baseline at 6 months
Primary outcome [33] 0 0
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
Timepoint [33] 0 0
Change from baseline at 12 months
Primary outcome [34] 0 0
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
Timepoint [34] 0 0
Baseline
Primary outcome [35] 0 0
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
Timepoint [35] 0 0
Change from baseline at 6 months
Primary outcome [36] 0 0
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
Timepoint [36] 0 0
Change from baseline at 12 months
Primary outcome [37] 0 0
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Timepoint [37] 0 0
Baseline
Primary outcome [38] 0 0
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Timepoint [38] 0 0
Change from baseline at 6 months
Primary outcome [39] 0 0
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
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
Timepoint [40] 0 0
Baseline
Primary outcome [41] 0 0
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
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
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
Timepoint [43] 0 0
Baseline
Primary outcome [44] 0 0
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
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
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
Timepoint [46] 0 0
Baseline
Primary outcome [47] 0 0
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
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
Timepoint [48] 0 0
Change from baseline at 12 months
Primary outcome [49] 0 0
2D.i.0 Respiratory Microbiome (Viruses) - Richness
Timepoint [49] 0 0
Baseline
Primary outcome [50] 0 0
2D.i.6 Respiratory Microbiome (Viruses) - Richness
Timepoint [50] 0 0
Change from baseline at 6 months
Primary outcome [51] 0 0
2D.i.12 Respiratory Microbiome (Viruses) - Richness
Timepoint [51] 0 0
Change from baseline at 12 months
Primary outcome [52] 0 0
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
Timepoint [52] 0 0
Baseline
Primary outcome [53] 0 0
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
Timepoint [53] 0 0
Change from baseline at 6 months
Primary outcome [54] 0 0
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
Timepoint [54] 0 0
Change from baseline at 12 months
Primary outcome [55] 0 0
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Timepoint [55] 0 0
Baseline
Primary outcome [56] 0 0
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Timepoint [56] 0 0
6 months
Primary outcome [57] 0 0
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Timepoint [57] 0 0
12 months
Primary outcome [58] 0 0
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
Timepoint [58] 0 0
Baseline
Primary outcome [59] 0 0
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
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
Timepoint [60] 0 0
Change from baseline at 12 months
Primary outcome [61] 0 0
3A.i.0 Diet - total energy intake
Timepoint [61] 0 0
Baseline
Primary outcome [62] 0 0
3A.i.6 Diet - total energy intake
Timepoint [62] 0 0
Change from baseline at 6 months
Primary outcome [63] 0 0
3A.i.12 Diet - total energy intake
Timepoint [63] 0 0
Change from baseline at 12 months
Primary outcome [64] 0 0
3B.i.0 Diet - percentage energy from core foods
Timepoint [64] 0 0
Baseline
Primary outcome [65] 0 0
3B.i.6 Diet - percentage energy from core foods
Timepoint [65] 0 0
Change from baseline at 6 months
Primary outcome [66] 0 0
3B.i.12 Diet - percentage energy from core foods
Timepoint [66] 0 0
Change from baseline at 12 months
Primary outcome [67] 0 0
3C.i.0 Diet - total macronutrients intake
Timepoint [67] 0 0
Baseline
Primary outcome [68] 0 0
3C.i.6 Diet - total macronutrients intake
Timepoint [68] 0 0
Change from baseline at 6 months
Primary outcome [69] 0 0
3C.i.12 Diet - total macronutrients intake
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
Timepoint [70] 0 0
Baseline
Primary outcome [71] 0 0
3C.ii.6 Diet - macronutrients proportion of total energy intake
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
Timepoint [72] 0 0
Change from baseline at 12 months
Primary outcome [73] 0 0
3D.i.0 Diet - total micronutrients intake
Timepoint [73] 0 0
Baseline
Primary outcome [74] 0 0
3D.i.6 Diet - total micronutrients intake
Timepoint [74] 0 0
Change from baseline at 6 months
Primary outcome [75] 0 0
3D.i.12 Diet - total micronutrients intake
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
Timepoint [76] 0 0
Baseline
Primary outcome [77] 0 0
3D.ii.6 Diet - micronutrients proportion of total energy intake
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
Timepoint [78] 0 0
Change from baseline at 12 months
Primary outcome [79] 0 0
3E.i.0 Diet - diet quality score
Timepoint [79] 0 0
Baseline
Primary outcome [80] 0 0
3E.i.6 Diet - diet quality score
Timepoint [80] 0 0
Change from baseline at 6 months
Primary outcome [81] 0 0
3E.i.12 Diet - diet quality score
Timepoint [81] 0 0
Change from baseline at 12 months
Secondary outcome [1] 0 0
4A.i.0 Faecal biomarkers - calprotectin
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
4A.i.6 Faecal biomarkers - calprotectin
Timepoint [2] 0 0
Change from baseline at 6 months
Secondary outcome [3] 0 0
4A.i.12 Faecal biomarkers - calprotectin
Timepoint [3] 0 0
Change from baseline at 12 months
Secondary outcome [4] 0 0
4A.ii.0 Faecal biomarkers - M2 pyruvate kinase
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
4A.ii.6 Faecal biomarkers - M2 pyruvate kinase
Timepoint [5] 0 0
Change from baseline at 6 months
Secondary outcome [6] 0 0
4A.ii.12 Faecal biomarkers - M2 pyruvate kinase
Timepoint [6] 0 0
Change from baseline at 12 months
Secondary outcome [7] 0 0
4A.iii.0 Faecal biomarkers - C-reactive protein
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
4A.iii.6 Faecal biomarkers - C-reactive protein
Timepoint [8] 0 0
Change from baseline at 6 months
Secondary outcome [9] 0 0
4A.iii.12 Faecal biomarkers - C-reactive protein
Timepoint [9] 0 0
Change from baseline at 12 months
Secondary outcome [10] 0 0
4A.iv.0 Faecal biomarkers - Interleukins
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
4A.iv.6 Faecal biomarkers - Interleukins
Timepoint [11] 0 0
Change from baseline at 6 months
Secondary outcome [12] 0 0
4A.iv.12 Faecal biomarkers - Interleukins
Timepoint [12] 0 0
Change from baseline at 12 months
Secondary outcome [13] 0 0
4B.i.0 Respiratory biomarkers - calprotectin
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
4B.i.6 Respiratory biomarkers - calprotectin
Timepoint [14] 0 0
Change from baseline at 6 months
Secondary outcome [15] 0 0
4B.i.12 Respiratory biomarkers - calprotectin
Timepoint [15] 0 0
Change from baseline at 12 months
Secondary outcome [16] 0 0
4B.ii.0 Respiratory biomarkers - C-reactive protein
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
4B.ii.6 Respiratory biomarkers - C-reactive protein
Timepoint [17] 0 0
Change from baseline at 6 months
Secondary outcome [18] 0 0
4B.ii.12 Respiratory biomarkers - C-reactive protein
Timepoint [18] 0 0
Change from baseline at 12 months
Secondary outcome [19] 0 0
4B.iii.0 Respiratory biomarkers - Interleukins
Timepoint [19] 0 0
Baseline
Secondary outcome [20] 0 0
4B.iii.6 Respiratory biomarkers - Interleukins
Timepoint [20] 0 0
Change from baseline at 6 months
Secondary outcome [21] 0 0
4B.iii.12 Respiratory biomarkers - Interleukins
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)
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)
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)
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)
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
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)
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)
Timepoint [28] 0 0
Baseline
Secondary outcome [29] 0 0
5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
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)
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)
Timepoint [31] 0 0
Baseline
Secondary outcome [32] 0 0
5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
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)
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)
Timepoint [34] 0 0
Baseline
Secondary outcome [35] 0 0
5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Timepoint [52] 0 0
Baseline
Secondary outcome [53] 0 0
5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
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)
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).
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).
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).
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).
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).
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).
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)
Timepoint [61] 0 0
Baseline
Secondary outcome [62] 0 0
6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
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)
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)
Timepoint [64] 0 0
Baseline
Secondary outcome [65] 0 0
6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
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)
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)
Timepoint [67] 0 0
Baseline
Secondary outcome [68] 0 0
6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
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)
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)
Timepoint [70] 0 0
Baseline
Secondary outcome [71] 0 0
6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
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)
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)
Timepoint [73] 0 0
Baseline
Secondary outcome [74] 0 0
6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
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)
Timepoint [75] 0 0
Change from baseline at 12 months
Secondary outcome [76] 0 0
6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
Timepoint [76] 0 0
6 months
Secondary outcome [77] 0 0
6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
Timepoint [77] 0 0
12 months
Secondary outcome [78] 0 0
6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
Timepoint [78] 0 0
6 months
Secondary outcome [79] 0 0
6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
Timepoint [79] 0 0
12 months
Secondary outcome [80] 0 0
6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
Timepoint [80] 0 0
6 months
Secondary outcome [81] 0 0
6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04071314
Trial related presentations / publications
Traini I, Chan SY, Menzies J, Hughes J, Coffey MJ, Katz T, McKay IR, Ooi CY, Leach ST, Krishnan U. Evaluating the Dietary Intake of Children With Esophageal Atresia: A Prospective, Controlled, Observational Study. J Pediatr Gastroenterol Nutr. 2022 Aug 1;75(2):221-226. doi: 10.1097/MPG.0000000000003498. Epub 2022 Jun 1.
Coffey MJ, McKay IR, Doumit M, Chuang S, Adams S, Stelzer-Braid S, Waters SA, Kasparian NA, Thomas T, Jaffe A, Katz T, Ooi CY. Evaluating the Alimentary and Respiratory Tracts in Health and disease (EARTH) research programme: a protocol for prospective, longitudinal, controlled, observational studies in children with chronic disease at an Australian tertiary paediatric hospital. BMJ Open. 2020 Apr 14;10(4):e033916. doi: 10.1136/bmjopen-2019-033916.
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
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04071314