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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
Titles & IDs
Public title
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
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Scientific title
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
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Secondary ID [1]
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0
HREC/18/SCHN/26
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Universal Trial Number (UTN)
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Trial acronym
EARTH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Hirschprung's Disease
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Obstructive Sleep Apnea
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0
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Healthy
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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
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Cystic fibrosis
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Respiratory
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0
0
0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Respiratory
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0
0
0
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Sleep apnoea
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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1A.i.0 Intestinal Microbiome (Bacteria) - Richness
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Assessment method [1]
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0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [1]
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0
Baseline
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Primary outcome [2]
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0
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
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Assessment method [2]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [2]
0
0
Change from baseline at 6 months
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Primary outcome [3]
0
0
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
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Assessment method [3]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [3]
0
0
Change from baseline at 12 months
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Primary outcome [4]
0
0
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
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Assessment method [4]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [4]
0
0
Baseline
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Primary outcome [5]
0
0
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
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Assessment method [5]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [5]
0
0
Change from baseline at 6 months
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Primary outcome [6]
0
0
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
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Assessment method [6]
0
0
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [6]
0
0
Change from baseline at 12 months
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Primary outcome [7]
0
0
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
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Assessment method [7]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [7]
0
0
Baseline
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Primary outcome [8]
0
0
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
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Assessment method [8]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [8]
0
0
6 months
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Primary outcome [9]
0
0
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
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Assessment method [9]
0
0
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [9]
0
0
12 months
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Primary outcome [10]
0
0
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
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Assessment method [10]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [10]
0
0
Baseline
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Primary outcome [11]
0
0
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
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Assessment method [11]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [11]
0
0
Change from baseline at 6 months
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Primary outcome [12]
0
0
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
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Assessment method [12]
0
0
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
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Timepoint [12]
0
0
Change from baseline at 12 months
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Primary outcome [13]
0
0
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
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Assessment method [13]
0
0
(assessed using LC-MS).
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Timepoint [13]
0
0
Baseline
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Primary outcome [14]
0
0
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
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Assessment method [14]
0
0
(assessed using LC-MS).
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Timepoint [14]
0
0
Change from baseline at 6 months
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Primary outcome [15]
0
0
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
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Assessment method [15]
0
0
(assessed using LC-MS).
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Timepoint [15]
0
0
Change from baseline at 12 months
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Primary outcome [16]
0
0
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
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Assessment method [16]
0
0
(assessed using LC-MS).
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Timepoint [16]
0
0
Baseline
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Primary outcome [17]
0
0
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
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Assessment method [17]
0
0
(assessed using LC-MS).
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Timepoint [17]
0
0
Change from baseline at 6 months
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Primary outcome [18]
0
0
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
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Assessment method [18]
0
0
(assessed using LC-MS).
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Timepoint [18]
0
0
Change from baseline at 12 months
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Primary outcome [19]
0
0
1D.i.0 Intestinal Microbiome (Viruses) - Richness
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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
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Assessment method [22]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
Query!
Timepoint [22]
0
0
Baseline
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Primary outcome [23]
0
0
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
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Assessment method [23]
0
0
Measurement of alpha diversity (assessed metagenomic sequencing).
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Timepoint [23]
0
0
Change from baseline at 6 months
Query!
Primary outcome [24]
0
0
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
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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.
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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
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Assessment method [61]
0
0
Kilojoules (assessed using a 24-hour recall or ACAES).
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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)
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Assessment method [67]
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0
Z-score.
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Timepoint [67]
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0
Baseline
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Secondary outcome [68]
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0
6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
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Assessment method [68]
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0
Z-score.
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Timepoint [68]
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0
Change from baseline at 6 months
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Secondary outcome [69]
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0
6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
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Assessment method [69]
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0
Z-score.
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Timepoint [69]
0
0
Change from baseline at 12 months
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Secondary outcome [70]
0
0
6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
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Assessment method [70]
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0
Z-score.
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Timepoint [70]
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0
Baseline
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Secondary outcome [71]
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0
6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
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Assessment method [71]
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0
Z-score.
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Timepoint [71]
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0
Change from baseline at 6 months
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Secondary outcome [72]
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0
6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
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Assessment method [72]
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0
Z-score.
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Timepoint [72]
0
0
Change from baseline at 12 months
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Secondary outcome [73]
0
0
6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
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Assessment method [73]
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0
Z-score.
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Timepoint [73]
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0
Baseline
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Secondary outcome [74]
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0
6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
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Assessment method [74]
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0
Z-score.
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Timepoint [74]
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0
Change from baseline at 6 months
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Secondary outcome [75]
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0
6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
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Assessment method [75]
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0
Z-score.
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Timepoint [75]
0
0
Change from baseline at 12 months
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Secondary outcome [76]
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0
6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
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Assessment method [76]
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0
During period from baseline to 6 months.
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Timepoint [76]
0
0
6 months
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Secondary outcome [77]
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6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
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Assessment method [77]
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0
During period from baseline to 12 months.
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Timepoint [77]
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0
12 months
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Secondary outcome [78]
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0
6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
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Assessment method [78]
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0
Days hospitalised during period from baseline to 6 months.
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Timepoint [78]
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0
6 months
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Secondary outcome [79]
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0
6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
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Assessment method [79]
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0
Days hospitalised during period from baseline to 12 months.
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Timepoint [79]
0
0
12 months
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Secondary outcome [80]
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0
6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
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Assessment method [80]
0
0
During period from baseline to 6 months.
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Timepoint [80]
0
0
6 months
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Secondary outcome [81]
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0
6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
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Assessment method [81]
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0
During period from baseline to 12 months.
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Timepoint [81]
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12 months
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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.
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Minimum age
No limit
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/03/2023
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04071314
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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.
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Public notes
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Contacts
Principal investigator
Name
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Michael J Coffey
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Address
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University of New South Wales
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Country
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Phone
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Fax
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0
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0
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Contact person for public queries
Name
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0
Michael J Coffey
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Address
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0
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Country
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0
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Phone
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0
61293825574
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
De-identified data and biological samples may be utilised by study investigators ONLY for the sole purpose of a research project.
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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