Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
Query!
Scientific title
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Query!
Secondary ID [1]
0
0
HREC/18/SCHN/26
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EARTH
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
0
0
Query!
Hirschprung's Disease
0
0
Query!
Obstructive Sleep Apnea
0
0
Query!
Healthy
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Cystic fibrosis
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Respiratory
0
0
0
0
Query!
Sleep apnoea
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
1A.i.0 Intestinal Microbiome (Bacteria) - Richness
Query!
Assessment method [1]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [1]
0
0
Baseline
Query!
Primary outcome [2]
0
0
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
Query!
Assessment method [2]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [2]
0
0
Change from baseline at 6 months
Query!
Primary outcome [3]
0
0
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
Query!
Assessment method [3]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [3]
0
0
Change from baseline at 12 months
Query!
Primary outcome [4]
0
0
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
Query!
Assessment method [4]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [4]
0
0
Baseline
Query!
Primary outcome [5]
0
0
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
Query!
Assessment method [5]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [5]
0
0
Change from baseline at 6 months
Query!
Primary outcome [6]
0
0
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
Query!
Assessment method [6]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [6]
0
0
Change from baseline at 12 months
Query!
Primary outcome [7]
0
0
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Query!
Assessment method [7]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [7]
0
0
Baseline
Query!
Primary outcome [8]
0
0
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Query!
Assessment method [8]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [8]
0
0
6 months
Query!
Primary outcome [9]
0
0
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Query!
Assessment method [9]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [9]
0
0
12 months
Query!
Primary outcome [10]
0
0
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Query!
Assessment method [10]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [10]
0
0
Baseline
Query!
Primary outcome [11]
0
0
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Query!
Assessment method [11]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [11]
0
0
Change from baseline at 6 months
Query!
Primary outcome [12]
0
0
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Query!
Assessment method [12]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [12]
0
0
Change from baseline at 12 months
Query!
Primary outcome [13]
0
0
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Query!
Assessment method [13]
0
0
(assessed using LC-MS).
Query!
Timepoint [13]
0
0
Baseline
Query!
Primary outcome [14]
0
0
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Query!
Assessment method [14]
0
0
(assessed using LC-MS).
Query!
Timepoint [14]
0
0
Change from baseline at 6 months
Query!
Primary outcome [15]
0
0
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Query!
Assessment method [15]
0
0
(assessed using LC-MS).
Query!
Timepoint [15]
0
0
Change from baseline at 12 months
Query!
Primary outcome [16]
0
0
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Query!
Assessment method [16]
0
0
(assessed using LC-MS).
Query!
Timepoint [16]
0
0
Baseline
Query!
Primary outcome [17]
0
0
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Query!
Assessment method [17]
0
0
(assessed using LC-MS).
Query!
Timepoint [17]
0
0
Change from baseline at 6 months
Query!
Primary outcome [18]
0
0
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Query!
Assessment method [18]
0
0
(assessed using LC-MS).
Query!
Timepoint [18]
0
0
Change from baseline at 12 months
Query!
Primary outcome [19]
0
0
1D.i.0 Intestinal Microbiome (Viruses) - Richness
Query!
Assessment method [19]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [19]
0
0
Baseline
Query!
Primary outcome [20]
0
0
1D.i.6 Intestinal Microbiome (Viruses) - Richness
Query!
Assessment method [20]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [20]
0
0
Change from baseline at 6 months
Query!
Primary outcome [21]
0
0
1D.i.12 Intestinal Microbiome (Viruses) - Richness
Query!
Assessment method [21]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [21]
0
0
Change from baseline at 12 months
Query!
Primary outcome [22]
0
0
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
Query!
Assessment method [22]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [22]
0
0
Baseline
Query!
Primary outcome [23]
0
0
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
Query!
Assessment method [23]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [23]
0
0
Change from baseline at 6 months
Query!
Primary outcome [24]
0
0
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
Query!
Assessment method [24]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [24]
0
0
Change from baseline at 12 months
Query!
Primary outcome [25]
0
0
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Query!
Assessment method [25]
0
0
Measurement of beta diversity (assessed metagenomic sequencing).
Query!
Timepoint [25]
0
0
Baseline
Query!
Primary outcome [26]
0
0
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Query!
Assessment method [26]
0
0
Measurement of beta diversity (assessed metagenomic sequencing).
Query!
Timepoint [26]
0
0
6 months
Query!
Primary outcome [27]
0
0
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Query!
Assessment method [27]
0
0
Measurement of beta diversity (assessed metagenomic sequencing).
Query!
Timepoint [27]
0
0
12 months
Query!
Primary outcome [28]
0
0
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Query!
Assessment method [28]
0
0
ANCOM analysis (assessed metagenomic sequencing).
Query!
Timepoint [28]
0
0
Baseline
Query!
Primary outcome [29]
0
0
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Query!
Assessment method [29]
0
0
ANCOM analysis (assessed metagenomic sequencing).
Query!
Timepoint [29]
0
0
Change from baseline at 6 months
Query!
Primary outcome [30]
0
0
1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Query!
Assessment method [30]
0
0
ANCOM analysis (assessed metagenomic sequencing).
Query!
Timepoint [30]
0
0
Change from baseline at 12 months
Query!
Primary outcome [31]
0
0
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
Query!
Assessment method [31]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [31]
0
0
Baseline
Query!
Primary outcome [32]
0
0
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
Query!
Assessment method [32]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [32]
0
0
Change from baseline at 6 months
Query!
Primary outcome [33]
0
0
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
Query!
Assessment method [33]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [33]
0
0
Change from baseline at 12 months
Query!
Primary outcome [34]
0
0
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
Query!
Assessment method [34]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [34]
0
0
Baseline
Query!
Primary outcome [35]
0
0
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
Query!
Assessment method [35]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [35]
0
0
Change from baseline at 6 months
Query!
Primary outcome [36]
0
0
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
Query!
Assessment method [36]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [36]
0
0
Change from baseline at 12 months
Query!
Primary outcome [37]
0
0
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Query!
Assessment method [37]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [37]
0
0
Baseline
Query!
Primary outcome [38]
0
0
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Query!
Assessment method [38]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [38]
0
0
Change from baseline at 6 months
Query!
Primary outcome [39]
0
0
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Query!
Assessment method [39]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [39]
0
0
Change from baseline at 12 months
Query!
Primary outcome [40]
0
0
2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Query!
Assessment method [40]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [40]
0
0
Baseline
Query!
Primary outcome [41]
0
0
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Query!
Assessment method [41]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [41]
0
0
Change from baseline at 6 months
Query!
Primary outcome [42]
0
0
2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Query!
Assessment method [42]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Query!
Timepoint [42]
0
0
Change from baseline at 12 months
Query!
Primary outcome [43]
0
0
2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Query!
Assessment method [43]
0
0
(assessed using LC-MS).
Query!
Timepoint [43]
0
0
Baseline
Query!
Primary outcome [44]
0
0
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Query!
Assessment method [44]
0
0
(assessed using LC-MS).
Query!
Timepoint [44]
0
0
Change from baseline at 6 months
Query!
Primary outcome [45]
0
0
2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Query!
Assessment method [45]
0
0
(assessed using LC-MS).
Query!
Timepoint [45]
0
0
Change from baseline at 12 months
Query!
Primary outcome [46]
0
0
2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Query!
Assessment method [46]
0
0
(assessed using LC-MS).
Query!
Timepoint [46]
0
0
Baseline
Query!
Primary outcome [47]
0
0
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Query!
Assessment method [47]
0
0
(assessed using LC-MS).
Query!
Timepoint [47]
0
0
Change from baseline at 6 months
Query!
Primary outcome [48]
0
0
2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Query!
Assessment method [48]
0
0
(assessed using LC-MS).
Query!
Timepoint [48]
0
0
Change from baseline at 12 months
Query!
Primary outcome [49]
0
0
2D.i.0 Respiratory Microbiome (Viruses) - Richness
Query!
Assessment method [49]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [49]
0
0
Baseline
Query!
Primary outcome [50]
0
0
2D.i.6 Respiratory Microbiome (Viruses) - Richness
Query!
Assessment method [50]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [50]
0
0
Change from baseline at 6 months
Query!
Primary outcome [51]
0
0
2D.i.12 Respiratory Microbiome (Viruses) - Richness
Query!
Assessment method [51]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [51]
0
0
Change from baseline at 12 months
Query!
Primary outcome [52]
0
0
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
Query!
Assessment method [52]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [52]
0
0
Baseline
Query!
Primary outcome [53]
0
0
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
Query!
Assessment method [53]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [53]
0
0
Change from baseline at 6 months
Query!
Primary outcome [54]
0
0
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
Query!
Assessment method [54]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [54]
0
0
Change from baseline at 12 months
Query!
Primary outcome [55]
0
0
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Query!
Assessment method [55]
0
0
Measurement of beta diversity (assessed metagenomic sequencing).
Query!
Timepoint [55]
0
0
Baseline
Query!
Primary outcome [56]
0
0
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Query!
Assessment method [56]
0
0
Measurement of beta diversity (assessed metagenomic sequencing).
Query!
Timepoint [56]
0
0
6 months
Query!
Primary outcome [57]
0
0
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Query!
Assessment method [57]
0
0
Measurement of beta diversity (assessed metagenomic sequencing).
Query!
Timepoint [57]
0
0
12 months
Query!
Primary outcome [58]
0
0
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
Query!
Assessment method [58]
0
0
ANCOM analysis (assessed metagenomic sequencing).
Query!
Timepoint [58]
0
0
Baseline
Query!
Primary outcome [59]
0
0
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
Query!
Assessment method [59]
0
0
ANCOM analysis (assessed metagenomic sequencing).
Query!
Timepoint [59]
0
0
Change from baseline at 6 months
Query!
Primary outcome [60]
0
0
2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
Query!
Assessment method [60]
0
0
ANCOM analysis (assessed metagenomic sequencing).
Query!
Timepoint [60]
0
0
Change from baseline at 12 months
Query!
Primary outcome [61]
0
0
3A.i.0 Diet - total energy intake
Query!
Assessment method [61]
0
0
Kilojoules (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [61]
0
0
Baseline
Query!
Primary outcome [62]
0
0
3A.i.6 Diet - total energy intake
Query!
Assessment method [62]
0
0
Kilojoules (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [62]
0
0
Change from baseline at 6 months
Query!
Primary outcome [63]
0
0
3A.i.12 Diet - total energy intake
Query!
Assessment method [63]
0
0
Kilojoules (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [63]
0
0
Change from baseline at 12 months
Query!
Primary outcome [64]
0
0
3B.i.0 Diet - percentage energy from core foods
Query!
Assessment method [64]
0
0
(assessed using a 24-hour recall or ACAES).
Query!
Timepoint [64]
0
0
Baseline
Query!
Primary outcome [65]
0
0
3B.i.6 Diet - percentage energy from core foods
Query!
Assessment method [65]
0
0
(assessed using a 24-hour recall or ACAES).
Query!
Timepoint [65]
0
0
Change from baseline at 6 months
Query!
Primary outcome [66]
0
0
3B.i.12 Diet - percentage energy from core foods
Query!
Assessment method [66]
0
0
(assessed using a 24-hour recall or ACAES).
Query!
Timepoint [66]
0
0
Change from baseline at 12 months
Query!
Primary outcome [67]
0
0
3C.i.0 Diet - total macronutrients intake
Query!
Assessment method [67]
0
0
Grams (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [67]
0
0
Baseline
Query!
Primary outcome [68]
0
0
3C.i.6 Diet - total macronutrients intake
Query!
Assessment method [68]
0
0
Grams (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [68]
0
0
Change from baseline at 6 months
Query!
Primary outcome [69]
0
0
3C.i.12 Diet - total macronutrients intake
Query!
Assessment method [69]
0
0
Grams (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [69]
0
0
Change from baseline at 12 months
Query!
Primary outcome [70]
0
0
3C.ii.0 Diet - macronutrients proportion of total energy intake
Query!
Assessment method [70]
0
0
Percentage (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [70]
0
0
Baseline
Query!
Primary outcome [71]
0
0
3C.ii.6 Diet - macronutrients proportion of total energy intake
Query!
Assessment method [71]
0
0
Percentage (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [71]
0
0
Change from baseline at 6 months
Query!
Primary outcome [72]
0
0
3C.ii.12 Diet - macronutrients proportion of total energy intake
Query!
Assessment method [72]
0
0
Percentage (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [72]
0
0
Change from baseline at 12 months
Query!
Primary outcome [73]
0
0
3D.i.0 Diet - total micronutrients intake
Query!
Assessment method [73]
0
0
Milligrams (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [73]
0
0
Baseline
Query!
Primary outcome [74]
0
0
3D.i.6 Diet - total micronutrients intake
Query!
Assessment method [74]
0
0
Milligrams (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [74]
0
0
Change from baseline at 6 months
Query!
Primary outcome [75]
0
0
3D.i.12 Diet - total micronutrients intake
Query!
Assessment method [75]
0
0
Milligrams (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [75]
0
0
Change from baseline at 12 months
Query!
Primary outcome [76]
0
0
3D.ii.0 Diet - micronutrients proportion of total energy intake
Query!
Assessment method [76]
0
0
Percentage (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [76]
0
0
Baseline
Query!
Primary outcome [77]
0
0
3D.ii.6 Diet - micronutrients proportion of total energy intake
Query!
Assessment method [77]
0
0
Percentage (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [77]
0
0
Change from baseline at 6 months
Query!
Primary outcome [78]
0
0
3D.ii.12 Diet - micronutrients proportion of total energy intake
Query!
Assessment method [78]
0
0
Percentage (assessed using a 24-hour recall or ACAES).
Query!
Timepoint [78]
0
0
Change from baseline at 12 months
Query!
Primary outcome [79]
0
0
3E.i.0 Diet - diet quality score
Query!
Assessment method [79]
0
0
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Query!
Timepoint [79]
0
0
Baseline
Query!
Primary outcome [80]
0
0
3E.i.6 Diet - diet quality score
Query!
Assessment method [80]
0
0
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Query!
Timepoint [80]
0
0
Change from baseline at 6 months
Query!
Primary outcome [81]
0
0
3E.i.12 Diet - diet quality score
Query!
Assessment method [81]
0
0
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Query!
Timepoint [81]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [1]
0
0
4A.i.0 Faecal biomarkers - calprotectin
Query!
Assessment method [1]
0
0
mg/kg (assessed using an ELISA).
Query!
Timepoint [1]
0
0
Baseline
Query!
Secondary outcome [2]
0
0
4A.i.6 Faecal biomarkers - calprotectin
Query!
Assessment method [2]
0
0
mg/kg (assessed using an ELISA).
Query!
Timepoint [2]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [3]
0
0
4A.i.12 Faecal biomarkers - calprotectin
Query!
Assessment method [3]
0
0
mg/kg (assessed using an ELISA).
Query!
Timepoint [3]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [4]
0
0
4A.ii.0 Faecal biomarkers - M2 pyruvate kinase
Query!
Assessment method [4]
0
0
U/mL (assessed using an ELISA).
Query!
Timepoint [4]
0
0
Baseline
Query!
Secondary outcome [5]
0
0
4A.ii.6 Faecal biomarkers - M2 pyruvate kinase
Query!
Assessment method [5]
0
0
U/mL (assessed using an ELISA).
Query!
Timepoint [5]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [6]
0
0
4A.ii.12 Faecal biomarkers - M2 pyruvate kinase
Query!
Assessment method [6]
0
0
U/mL (assessed using an ELISA).
Query!
Timepoint [6]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [7]
0
0
4A.iii.0 Faecal biomarkers - C-reactive protein
Query!
Assessment method [7]
0
0
mg/L (assessed using an ELISA).
Query!
Timepoint [7]
0
0
Baseline
Query!
Secondary outcome [8]
0
0
4A.iii.6 Faecal biomarkers - C-reactive protein
Query!
Assessment method [8]
0
0
mg/L (assessed using an ELISA).
Query!
Timepoint [8]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [9]
0
0
4A.iii.12 Faecal biomarkers - C-reactive protein
Query!
Assessment method [9]
0
0
mg/L (assessed using an ELISA).
Query!
Timepoint [9]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [10]
0
0
4A.iv.0 Faecal biomarkers - Interleukins
Query!
Assessment method [10]
0
0
IU (assessed using an ELISA).
Query!
Timepoint [10]
0
0
Baseline
Query!
Secondary outcome [11]
0
0
4A.iv.6 Faecal biomarkers - Interleukins
Query!
Assessment method [11]
0
0
IU (assessed using an ELISA).
Query!
Timepoint [11]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [12]
0
0
4A.iv.12 Faecal biomarkers - Interleukins
Query!
Assessment method [12]
0
0
IU (assessed using an ELISA).
Query!
Timepoint [12]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [13]
0
0
4B.i.0 Respiratory biomarkers - calprotectin
Query!
Assessment method [13]
0
0
mg/kg (assessed using an ELISA).
Query!
Timepoint [13]
0
0
Baseline
Query!
Secondary outcome [14]
0
0
4B.i.6 Respiratory biomarkers - calprotectin
Query!
Assessment method [14]
0
0
mg/kg (assessed using an ELISA).
Query!
Timepoint [14]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [15]
0
0
4B.i.12 Respiratory biomarkers - calprotectin
Query!
Assessment method [15]
0
0
mg/kg (assessed using an ELISA).
Query!
Timepoint [15]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [16]
0
0
4B.ii.0 Respiratory biomarkers - C-reactive protein
Query!
Assessment method [16]
0
0
mg/L (assessed using an ELISA).
Query!
Timepoint [16]
0
0
Baseline
Query!
Secondary outcome [17]
0
0
4B.ii.6 Respiratory biomarkers - C-reactive protein
Query!
Assessment method [17]
0
0
mg/L (assessed using an ELISA).
Query!
Timepoint [17]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [18]
0
0
4B.ii.12 Respiratory biomarkers - C-reactive protein
Query!
Assessment method [18]
0
0
mg/L (assessed using an ELISA).
Query!
Timepoint [18]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [19]
0
0
4B.iii.0 Respiratory biomarkers - Interleukins
Query!
Assessment method [19]
0
0
IU (assessed using an ELISA).
Query!
Timepoint [19]
0
0
Baseline
Query!
Secondary outcome [20]
0
0
4B.iii.6 Respiratory biomarkers - Interleukins
Query!
Assessment method [20]
0
0
IU (assessed using an ELISA).
Query!
Timepoint [20]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [21]
0
0
4B.iii.12 Respiratory biomarkers - Interleukins
Query!
Assessment method [21]
0
0
IU (assessed using an ELISA).
Query!
Timepoint [21]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [22]
0
0
5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Query!
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.
Query!
Timepoint [22]
0
0
Baseline
Query!
Secondary outcome [23]
0
0
5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Query!
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.
Query!
Timepoint [23]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [24]
0
0
5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Query!
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.
Query!
Timepoint [24]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [25]
0
0
5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Query!
Assessment method [25]
0
0
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Query!
Timepoint [25]
0
0
Baseline
Query!
Secondary outcome [26]
0
0
5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Query!
Assessment method [26]
0
0
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Query!
Timepoint [26]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [27]
0
0
5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Query!
Assessment method [27]
0
0
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Query!
Timepoint [27]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [28]
0
0
5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Query!
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.
Query!
Timepoint [28]
0
0
Baseline
Query!
Secondary outcome [29]
0
0
5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Query!
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.
Query!
Timepoint [29]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [30]
0
0
5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Query!
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.
Query!
Timepoint [30]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [31]
0
0
5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Query!
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.
Query!
Timepoint [31]
0
0
Baseline
Query!
Secondary outcome [32]
0
0
5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Query!
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.
Query!
Timepoint [32]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [33]
0
0
5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Query!
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.
Query!
Timepoint [33]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [34]
0
0
5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Query!
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.
Query!
Timepoint [34]
0
0
Baseline
Query!
Secondary outcome [35]
0
0
5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Query!
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.
Query!
Timepoint [35]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [36]
0
0
5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Query!
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.
Query!
Timepoint [36]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [37]
0
0
5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Query!
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.
Query!
Timepoint [37]
0
0
Baseline
Query!
Secondary outcome [38]
0
0
5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Query!
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.
Query!
Timepoint [38]
0
0
6 months
Query!
Secondary outcome [39]
0
0
5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Query!
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.
Query!
Timepoint [39]
0
0
12 months
Query!
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)
Query!
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.
Query!
Timepoint [40]
0
0
Baseline
Query!
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)
Query!
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.
Query!
Timepoint [41]
0
0
6 months
Query!
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)
Query!
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.
Query!
Timepoint [42]
0
0
12 months
Query!
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)
Query!
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.
Query!
Timepoint [43]
0
0
Baseline
Query!
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)
Query!
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.
Query!
Timepoint [44]
0
0
6 months
Query!
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)
Query!
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.
Query!
Timepoint [45]
0
0
12 months
Query!
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)
Query!
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.
Query!
Timepoint [46]
0
0
Baseline
Query!
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)
Query!
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.
Query!
Timepoint [47]
0
0
Change from baseline at 6 months
Query!
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)
Query!
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.
Query!
Timepoint [48]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [49]
0
0
5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Query!
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.
Query!
Timepoint [49]
0
0
Baseline
Query!
Secondary outcome [50]
0
0
5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Query!
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.
Query!
Timepoint [50]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [51]
0
0
5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Query!
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.
Query!
Timepoint [51]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [52]
0
0
5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Query!
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.
Query!
Timepoint [52]
0
0
Baseline
Query!
Secondary outcome [53]
0
0
5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Query!
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.
Query!
Timepoint [53]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [54]
0
0
5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Query!
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.
Query!
Timepoint [54]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [55]
0
0
5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Query!
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.
Query!
Timepoint [55]
0
0
Baseline
Query!
Secondary outcome [56]
0
0
5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Query!
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.
Query!
Timepoint [56]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [57]
0
0
5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Query!
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.
Query!
Timepoint [57]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [58]
0
0
5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Query!
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.
Query!
Timepoint [58]
0
0
Baseline
Query!
Secondary outcome [59]
0
0
5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Query!
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.
Query!
Timepoint [59]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [60]
0
0
5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Query!
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.
Query!
Timepoint [60]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [61]
0
0
6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Query!
Assessment method [61]
0
0
Z-score.
Query!
Timepoint [61]
0
0
Baseline
Query!
Secondary outcome [62]
0
0
6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Query!
Assessment method [62]
0
0
Z-score.
Query!
Timepoint [62]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [63]
0
0
6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Query!
Assessment method [63]
0
0
Z-score.
Query!
Timepoint [63]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [64]
0
0
6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Query!
Assessment method [64]
0
0
Z-score.
Query!
Timepoint [64]
0
0
Baseline
Query!
Secondary outcome [65]
0
0
6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Query!
Assessment method [65]
0
0
Z-score.
Query!
Timepoint [65]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [66]
0
0
6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Query!
Assessment method [66]
0
0
Z-score.
Query!
Timepoint [66]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [67]
0
0
6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Query!
Assessment method [67]
0
0
Z-score.
Query!
Timepoint [67]
0
0
Baseline
Query!
Secondary outcome [68]
0
0
6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Query!
Assessment method [68]
0
0
Z-score.
Query!
Timepoint [68]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [69]
0
0
6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Query!
Assessment method [69]
0
0
Z-score.
Query!
Timepoint [69]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [70]
0
0
6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Query!
Assessment method [70]
0
0
Z-score.
Query!
Timepoint [70]
0
0
Baseline
Query!
Secondary outcome [71]
0
0
6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Query!
Assessment method [71]
0
0
Z-score.
Query!
Timepoint [71]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [72]
0
0
6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Query!
Assessment method [72]
0
0
Z-score.
Query!
Timepoint [72]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [73]
0
0
6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Query!
Assessment method [73]
0
0
Z-score.
Query!
Timepoint [73]
0
0
Baseline
Query!
Secondary outcome [74]
0
0
6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Query!
Assessment method [74]
0
0
Z-score.
Query!
Timepoint [74]
0
0
Change from baseline at 6 months
Query!
Secondary outcome [75]
0
0
6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Query!
Assessment method [75]
0
0
Z-score.
Query!
Timepoint [75]
0
0
Change from baseline at 12 months
Query!
Secondary outcome [76]
0
0
6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
Query!
Assessment method [76]
0
0
During period from baseline to 6 months.
Query!
Timepoint [76]
0
0
6 months
Query!
Secondary outcome [77]
0
0
6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
Query!
Assessment method [77]
0
0
During period from baseline to 12 months.
Query!
Timepoint [77]
0
0
12 months
Query!
Secondary outcome [78]
0
0
6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
Query!
Assessment method [78]
0
0
Days hospitalised during period from baseline to 6 months.
Query!
Timepoint [78]
0
0
6 months
Query!
Secondary outcome [79]
0
0
6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
Query!
Assessment method [79]
0
0
Days hospitalised during period from baseline to 12 months.
Query!
Timepoint [79]
0
0
12 months
Query!
Secondary outcome [80]
0
0
6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
Query!
Assessment method [80]
0
0
During period from baseline to 6 months.
Query!
Timepoint [80]
0
0
6 months
Query!
Secondary outcome [81]
0
0
6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
Query!
Assessment method [81]
0
0
During period from baseline to 12 months.
Query!
Timepoint [81]
0
0
12 months
Query!
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.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Unknown status
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/04/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
13/03/2023
Query!
Actual
Query!
Sample size
Target
72
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Sydney Children's Hospital - Randwick
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The University of New South Wales
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04071314
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Michael J Coffey
Query!
Address
0
0
University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Michael J Coffey
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
61293825574
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04071314
Download to PDF