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Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program. (EARTH)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071314
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Michael Coffey, The University of New South Wales

Tracking Information
First Submitted Date August 21, 2019
First Posted Date August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date April 18, 2018
Estimated Primary Completion Date March 13, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2019)
  • 1A.i.0 Intestinal Microbiome (Bacteria) - Richness [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.i.6 Intestinal Microbiome (Bacteria) - Richness [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.i.12 Intestinal Microbiome (Bacteria) - Richness [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances [ Time Frame: Baseline ]
    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances [ Time Frame: 6 months ]
    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances [ Time Frame: 12 months ]
    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria [ Time Frame: Baseline ]
    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria [ Time Frame: Change from baseline at 6 months ]
    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria [ Time Frame: Change from baseline at 12 months ]
    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
  • 1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins [ Time Frame: Baseline ]
    (assessed using LC-MS).
  • 1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins [ Time Frame: Change from baseline at 6 months ]
    (assessed using LC-MS).
  • 1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins [ Time Frame: Change from baseline at 12 months ]
    (assessed using LC-MS).
  • 1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites [ Time Frame: Baseline ]
    (assessed using LC-MS).
  • 1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites [ Time Frame: Change from baseline at 6 months ]
    (assessed using LC-MS).
  • 1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites [ Time Frame: Change from baseline at 12 months ]
    (assessed using LC-MS).
  • 1D.i.0 Intestinal Microbiome (Viruses) - Richness [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 1D.i.6 Intestinal Microbiome (Viruses) - Richness [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 1D.i.12 Intestinal Microbiome (Viruses) - Richness [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity [ Time Frame: Baseline ]
    Measurement of beta diversity (assessed metagenomic sequencing).
  • 1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity [ Time Frame: 6 months ]
    Measurement of beta diversity (assessed metagenomic sequencing).
  • 1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity [ Time Frame: 12 months ]
    Measurement of beta diversity (assessed metagenomic sequencing).
  • 1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses. [ Time Frame: Baseline ]
    ANCOM analysis (assessed metagenomic sequencing).
  • 1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses. [ Time Frame: Change from baseline at 6 months ]
    ANCOM analysis (assessed metagenomic sequencing).
  • 1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses. [ Time Frame: Change from baseline at 12 months ]
    ANCOM analysis (assessed metagenomic sequencing).
  • 2A.i.0 Respiratory Microbiome (Bacteria) - Richness [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.i.6 Respiratory Microbiome (Bacteria) - Richness [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.i.12 Respiratory Microbiome (Bacteria) - Richness [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances [ Time Frame: Baseline ]
    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances [ Time Frame: Change from baseline at 6 months ]
    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances [ Time Frame: Change from baseline at 12 months ]
    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria [ Time Frame: Baseline ]
    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria [ Time Frame: Change from baseline at 6 months ]
    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria [ Time Frame: Change from baseline at 12 months ]
    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
  • 2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins [ Time Frame: Baseline ]
    (assessed using LC-MS).
  • 2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins [ Time Frame: Change from baseline at 6 months ]
    (assessed using LC-MS).
  • 2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins [ Time Frame: Change from baseline at 12 months ]
    (assessed using LC-MS).
  • 2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites [ Time Frame: Baseline ]
    (assessed using LC-MS).
  • 2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites [ Time Frame: Change from baseline at 6 months ]
    (assessed using LC-MS).
  • 2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites [ Time Frame: Change from baseline at 12 months ]
    (assessed using LC-MS).
  • 2D.i.0 Respiratory Microbiome (Viruses) - Richness [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 2D.i.6 Respiratory Microbiome (Viruses) - Richness [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 2D.i.12 Respiratory Microbiome (Viruses) - Richness [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index [ Time Frame: Baseline ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index [ Time Frame: Change from baseline at 6 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index [ Time Frame: Change from baseline at 12 months ]
    Measurement of alpha diversity (assessed metagenomic sequencing).
  • 2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity [ Time Frame: Baseline ]
    Measurement of beta diversity (assessed metagenomic sequencing).
  • 2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity [ Time Frame: 6 months ]
    Measurement of beta diversity (assessed metagenomic sequencing).
  • 2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity [ Time Frame: 12 months ]
    Measurement of beta diversity (assessed metagenomic sequencing).
  • 2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses [ Time Frame: Baseline ]
    ANCOM analysis (assessed metagenomic sequencing).
  • 2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses [ Time Frame: Change from baseline at 6 months ]
    ANCOM analysis (assessed metagenomic sequencing).
  • 2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses [ Time Frame: Change from baseline at 12 months ]
    ANCOM analysis (assessed metagenomic sequencing).
  • 3A.i.0 Diet - total energy intake [ Time Frame: Baseline ]
    Kilojoules (assessed using a 24-hour recall or ACAES).
  • 3A.i.6 Diet - total energy intake [ Time Frame: Change from baseline at 6 months ]
    Kilojoules (assessed using a 24-hour recall or ACAES).
  • 3A.i.12 Diet - total energy intake [ Time Frame: Change from baseline at 12 months ]
    Kilojoules (assessed using a 24-hour recall or ACAES).
  • 3B.i.0 Diet - percentage energy from core foods [ Time Frame: Baseline ]
    (assessed using a 24-hour recall or ACAES).
  • 3B.i.6 Diet - percentage energy from core foods [ Time Frame: Change from baseline at 6 months ]
    (assessed using a 24-hour recall or ACAES).
  • 3B.i.12 Diet - percentage energy from core foods [ Time Frame: Change from baseline at 12 months ]
    (assessed using a 24-hour recall or ACAES).
  • 3C.i.0 Diet - total macronutrients intake [ Time Frame: Baseline ]
    Grams (assessed using a 24-hour recall or ACAES).
  • 3C.i.6 Diet - total macronutrients intake [ Time Frame: Change from baseline at 6 months ]
    Grams (assessed using a 24-hour recall or ACAES).
  • 3C.i.12 Diet - total macronutrients intake [ Time Frame: Change from baseline at 12 months ]
    Grams (assessed using a 24-hour recall or ACAES).
  • 3C.ii.0 Diet - macronutrients proportion of total energy intake [ Time Frame: Baseline ]
    Percentage (assessed using a 24-hour recall or ACAES).
  • 3C.ii.6 Diet - macronutrients proportion of total energy intake [ Time Frame: Change from baseline at 6 months ]
    Percentage (assessed using a 24-hour recall or ACAES).
  • 3C.ii.12 Diet - macronutrients proportion of total energy intake [ Time Frame: Change from baseline at 12 months ]
    Percentage (assessed using a 24-hour recall or ACAES).
  • 3D.i.0 Diet - total micronutrients intake [ Time Frame: Baseline ]
    Milligrams (assessed using a 24-hour recall or ACAES).
  • 3D.i.6 Diet - total micronutrients intake [ Time Frame: Change from baseline at 6 months ]
    Milligrams (assessed using a 24-hour recall or ACAES).
  • 3D.i.12 Diet - total micronutrients intake [ Time Frame: Change from baseline at 12 months ]
    Milligrams (assessed using a 24-hour recall or ACAES).
  • 3D.ii.0 Diet - micronutrients proportion of total energy intake [ Time Frame: Baseline ]
    Percentage (assessed using a 24-hour recall or ACAES).
  • 3D.ii.6 Diet - micronutrients proportion of total energy intake [ Time Frame: Change from baseline at 6 months ]
    Percentage (assessed using a 24-hour recall or ACAES).
  • 3D.ii.12 Diet - micronutrients proportion of total energy intake [ Time Frame: Change from baseline at 12 months ]
    Percentage (assessed using a 24-hour recall or ACAES).
  • 3E.i.0 Diet - diet quality score [ Time Frame: Baseline ]
    Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
  • 3E.i.6 Diet - diet quality score [ Time Frame: Change from baseline at 6 months ]
    Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
  • 3E.i.12 Diet - diet quality score [ Time Frame: Change from baseline at 12 months ]
    Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 24, 2019)
  • 4A.i.0 Faecal biomarkers - calprotectin [ Time Frame: Baseline ]
    mg/kg (assessed using an ELISA).
  • 4A.i.6 Faecal biomarkers - calprotectin [ Time Frame: Change from baseline at 6 months ]
    mg/kg (assessed using an ELISA).
  • 4A.i.12 Faecal biomarkers - calprotectin [ Time Frame: Change from baseline at 12 months ]
    mg/kg (assessed using an ELISA).
  • 4A.ii.0 Faecal biomarkers - M2 pyruvate kinase [ Time Frame: Baseline ]
    U/mL (assessed using an ELISA).
  • 4A.ii.6 Faecal biomarkers - M2 pyruvate kinase [ Time Frame: Change from baseline at 6 months ]
    U/mL (assessed using an ELISA).
  • 4A.ii.12 Faecal biomarkers - M2 pyruvate kinase [ Time Frame: Change from baseline at 12 months ]
    U/mL (assessed using an ELISA).
  • 4A.iii.0 Faecal biomarkers - C-reactive protein [ Time Frame: Baseline ]
    mg/L (assessed using an ELISA).
  • 4A.iii.6 Faecal biomarkers - C-reactive protein [ Time Frame: Change from baseline at 6 months ]
    mg/L (assessed using an ELISA).
  • 4A.iii.12 Faecal biomarkers - C-reactive protein [ Time Frame: Change from baseline at 12 months ]
    mg/L (assessed using an ELISA).
  • 4A.iv.0 Faecal biomarkers - Interleukins [ Time Frame: Baseline ]
    IU (assessed using an ELISA).
  • 4A.iv.6 Faecal biomarkers - Interleukins [ Time Frame: Change from baseline at 6 months ]
    IU (assessed using an ELISA).
  • 4A.iv.12 Faecal biomarkers - Interleukins [ Time Frame: Change from baseline at 12 months ]
    IU (assessed using an ELISA).
  • 4B.i.0 Respiratory biomarkers - calprotectin [ Time Frame: Baseline ]
    mg/kg (assessed using an ELISA).
  • 4B.i.6 Respiratory biomarkers - calprotectin [ Time Frame: Change from baseline at 6 months ]
    mg/kg (assessed using an ELISA).
  • 4B.i.12 Respiratory biomarkers - calprotectin [ Time Frame: Change from baseline at 12 months ]
    mg/kg (assessed using an ELISA).
  • 4B.ii.0 Respiratory biomarkers - C-reactive protein [ Time Frame: Baseline ]
    mg/L (assessed using an ELISA).
  • 4B.ii.6 Respiratory biomarkers - C-reactive protein [ Time Frame: Change from baseline at 6 months ]
    mg/L (assessed using an ELISA).
  • 4B.ii.12 Respiratory biomarkers - C-reactive protein [ Time Frame: Change from baseline at 12 months ]
    mg/L (assessed using an ELISA).
  • 4B.iii.0 Respiratory biomarkers - Interleukins [ Time Frame: Baseline ]
    IU (assessed using an ELISA).
  • 4B.iii.6 Respiratory biomarkers - Interleukins [ Time Frame: Change from baseline at 6 months ]
    IU (assessed using an ELISA).
  • 4B.iii.12 Respiratory biomarkers - Interleukins [ Time Frame: Change from baseline at 12 months ]
    IU (assessed using an ELISA).
  • 5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months) [ Time Frame: Baseline ]
    Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
  • 5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months) [ Time Frame: Change from baseline at 6 months ]
    Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
  • 5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months) [ Time Frame: Change from baseline at 12 months ]
    Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
  • 5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years) [ Time Frame: Baseline ]
    Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years) [ Time Frame: Change from baseline at 6 months ]
    Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years) [ Time Frame: Change from baseline at 12 months ]
    Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years) [ Time Frame: Baseline ]
    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.
  • 5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years) [ Time Frame: Change from baseline at 6 months ]
    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.
  • 5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years) [ Time Frame: Change from baseline at 12 months ]
    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.
  • 5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years) [ Time Frame: Baseline ]
    Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years) [ Time Frame: Change from baseline at 6 months ]
    Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years) [ Time Frame: Change from baseline at 12 months ]
    Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years) [ Time Frame: Baseline ]
    Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years) [ Time Frame: Change from baseline at 6 months ]
    Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
  • 5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years) [ Time Frame: Change from baseline at 12 months ]
    Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.
  • 5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3) [ Time Frame: Baseline ]
    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.
  • 5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3) [ Time Frame: 6 months ]
    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.
  • 5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3) [ Time Frame: 12 months ]
    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.
  • 5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older) [ Time Frame: Baseline ]
    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.
  • 5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older) [ Time Frame: 6 months ]
    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.
  • 5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older) [ Time Frame: 12 months ]
    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.
  • 5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older) [ Time Frame: Baseline ]
    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.
  • 5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older) [ Time Frame: 6 months ]
    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.
  • 5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older) [ Time Frame: 12 months ]
    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.
  • 5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4) [ Time Frame: Baseline ]
    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.
  • 5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4) [ Time Frame: Change from baseline at 6 months ]
    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.
  • 5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4) [ Time Frame: Change from baseline at 12 months ]
    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.
  • 5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older) [ Time Frame: Baseline ]
    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.
  • 5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older) [ Time Frame: Change from baseline at 6 months ]
    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.
  • 5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older) [ Time Frame: Change from baseline at 12 months ]
    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.
  • 5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older) [ Time Frame: Baseline ]
    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.
  • 5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older) [ Time Frame: Change from baseline at 6 months ]
    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.
  • 5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older) [ Time Frame: Change from baseline at 12 months ]
    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.
  • 5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years). [ Time Frame: Baseline ]
    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.
  • 5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years). [ Time Frame: Change from baseline at 6 months ]
    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.
  • 5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years). [ Time Frame: Change from baseline at 12 months ]
    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.
  • 5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years). [ Time Frame: Baseline ]
    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.
  • 5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years). [ Time Frame: Change from baseline at 6 months ]
    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.
  • 5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years). [ Time Frame: Change from baseline at 12 months ]
    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.
  • 6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years) [ Time Frame: Baseline ]
    Z-score.
  • 6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years) [ Time Frame: Change from baseline at 6 months ]
    Z-score.
  • 6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years) [ Time Frame: Change from baseline at 12 months ]
    Z-score.
  • 6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years) [ Time Frame: Baseline ]
    Z-score.
  • 6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years) [ Time Frame: Change from baseline at 6 months ]
    Z-score.
  • 6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years) [ Time Frame: Change from baseline at 12 months ]
    Z-score.
  • 6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years) [ Time Frame: Baseline ]
    Z-score.
  • 6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years) [ Time Frame: Change from baseline at 6 months ]
    Z-score.
  • 6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years) [ Time Frame: Change from baseline at 12 months ]
    Z-score.
  • 6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years) [ Time Frame: Baseline ]
    Z-score.
  • 6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years) [ Time Frame: Change from baseline at 6 months ]
    Z-score.
  • 6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years) [ Time Frame: Change from baseline at 12 months ]
    Z-score.
  • 6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years) [ Time Frame: Baseline ]
    Z-score.
  • 6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years) [ Time Frame: Change from baseline at 6 months ]
    Z-score.
  • 6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years) [ Time Frame: Change from baseline at 12 months ]
    Z-score.
  • 6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations [ Time Frame: 6 months ]
    During period from baseline to 6 months.
  • 6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations [ Time Frame: 12 months ]
    During period from baseline to 12 months.
  • 6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations [ Time Frame: 6 months ]
    Days hospitalised during period from baseline to 6 months.
  • 6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations [ Time Frame: 12 months ]
    Days hospitalised during period from baseline to 12 months.
  • 6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations [ Time Frame: 6 months ]
    During period from baseline to 6 months.
  • 6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations [ Time Frame: 12 months ]
    During period from baseline to 12 months.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Official Title Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
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.

Detailed Description

The objective of this research program is to evaluate and compare children with a chronic gastrointestinal and/or respiratory condition and age and gender matched HC. The primary objectives include analysing the intestinal and respiratory microbiomes (using an integrated "omics" approach) and dietary intake using validated, food frequency quetsionnaires. The secondary objectives include evaluating:

  1. Known inflammatory biomarkers.
  2. Symptomatology and health-related quality of life (HRQOL) using validated measures.
  3. Phenotypic and clinical information.
  4. Sociodemographic factors Additional secondary objectives include correlating within children with the same condition: (i) dietary intake with the intestinal microbiome; (ii) dietary intake with the respiratory microbiome; and (iii) the intestinal and respiratory microbiomes.

The investigators hypothesise that:

(i) Children with chronic gastrointestinal and/or respiratory conditions will have altered intestinal and respiratory microbiomes compared to healthy children, and (ii) Diet plays a key role in influencing the intestinal and respiratory microbiomes and this may impact on clinical outcomes, biomarkers of disease, and health-related quality of life.

To our knowledge, this program will enable the first series of studies comparing the intestinal and respiratory microbiomes and diet in children with chronic gastrointestinal and/or respiratory conditions. Initial results will be hypothesis-generating and used to direct future studies tailored to a specific focus or line of inquiry. Additionally, studies from this research program have potential for direct translation into clinical care as diet is a highly modifiable factor.

Study design. The EARTH program provides a framework for a series of prospective, longitudinal, controlled, observational studies, with each individual study comparing children with a chronic gastrointestinal and/or respiratory condition to HC. A single healthy control group will be used for comparison against all conditions. The standardised methodological approach will also allow for comparisons between different health conditions.

Procedures.

Each participant will be assessed on three occasions over a 12-month period; at study entry, 6- and 12-month follow-up. At each time-point, the following will be collected:

  • A stool sample;
  • An oropharyngeal swab or sputum sample (a sputum sample will be obtained in children able to expectorate and an oropharyngeal swab will be collected in children unable to expectorate);
  • Dietary intake measured using the Australian Child and Adolescent Eating Survey (ACAES) (2 to 18 years) or 24-hour food recall (0 up to 2 years);
  • A secure, password-protected online survey comprising:

    i. PedsQL Infant Scales (0-2yr) & Gastrointestinal Symptoms Module (2-18yr),41-43 tailored to age; ii. Rome IV Questionnaire (0 to 18 years); iii. Spence Children's Anxiety Scale (3 to 18 years); iv. Short Mood and Feelings Questionnaires (6 to 18 years); v. Clinical and biochemical results obtained through routine care and hospitalisations (if available); vi. Sociodemographic factors (baseline survey only);

  • Anthropometrics: height, weight and BMI z-scores.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • A stool sample;
  • An oropharyngeal swab or sputum sample (a sputum sample will be obtained in children able to expectorate and an oropharyngeal swab will be collected in children unable to expectorate).
Sampling Method Non-Probability Sample
Study Population Studies will be carried out at a single centre; the Sydney Children's Hospital (SCH) in Randwick, Australia. SCH is a tertiary paediatric hospital. Participants with chronic gastrointestinal and/or respiratory conditions will be approached at their routine clinic appointments in the outpatient department. Flyers will be placed in the hospital for recruitment of HC.
Condition
  • Cystic Fibrosis
  • Hirschprung's Disease
  • Obstructive Sleep Apnea
  • Healthy
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 24, 2019)
72
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 13, 2023
Estimated Primary Completion Date March 13, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Michael J Coffey 61293825574 michael.coffey@unsw.edu.au
Contact: Chee (Keith) Y Ooi 61293825512 keith.ooi@unsw.edu.au
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04071314
Other Study ID Numbers HREC/18/SCHN/26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: De-identified data and biological samples may be utilised by study investigators ONLY for the sole purpose of a research project.
Responsible Party Dr Michael Coffey, The University of New South Wales
Study Sponsor The University of New South Wales
Collaborators Not Provided
Investigators
Principal Investigator: Michael J Coffey University of New South Wales
Principal Investigator: Chee (Keith) Y Ooi University of New South Wales
PRS Account The University of New South Wales
Verification Date August 2019