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Cystic FibrosisEARTHNCT04071314

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

An observational study of Cystic Fibrosis and Hirschprung's Disease, run by The University of New South Wales at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
How many people
72 participants
Where
1 siteAustralia
Study dates
18 Apr 2018to 13 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Michael J Coffey contact

61293825574

michael.coffey@unsw.edu.au

Chee (Keith) Y Ooi contact

61293825512

keith.ooi@unsw.edu.au

Australia1 site, 1 recruiting

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

    Michael J Coffey, 011 61 2 9382 5574, michael.coffey@unsw.edu.au

    Chee (Keith) Y Ooi, 011 61 2 9382 5512, keith.ooi@unsw.edu.au

    Recruiting

Other trials in Australia

About this study

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.

Read more

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.

Read the 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:
  1. 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.
Keywords
Microbiota, Gastrointestinal Microbiome, Diet, Signs and Symptoms, Quality of Life, Anxiety, Depression
Medical subject headings
Cystic Fibrosis, Sleep Apnea, Obstructive, Signs and Symptoms, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04071314
Study groupRoleWhat they receive
Cystic fibrosisChildren diagnosed with cystic fibrosis. Children aged between 0 and 18 years.
Hirschsprung's diseaseChildren diagnosed with Hirschsprung's disease. Children aged between 0 and 18 years.
Obstructive sleep apnoeaChildren diagnosed with obstructive sleep apnoea. Children aged between 0 and 18 years.
Healthy controlsChildren free of any chronic health condition. Children aged between 0 and 18 years.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1A.i.0 Intestinal Microbiome (Bacteria) - Richness

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  2. 1A.i.6 Intestinal Microbiome (Bacteria) - Richness

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  3. 1A.i.12 Intestinal Microbiome (Bacteria) - Richness

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  4. 1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  5. 1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  6. 1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  7. 1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances

    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  8. 1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances

    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: 6 months

  9. 1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances

    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: 12 months

  10. 1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria

    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  11. 1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria

    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  12. 1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria

    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  13. 1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins

    (assessed using LC-MS).

    Measured: Baseline

  14. 1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins

    (assessed using LC-MS).

    Measured: Change from baseline at 6 months

  15. 1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins

    (assessed using LC-MS).

    Measured: Change from baseline at 12 months

  16. 1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites

    (assessed using LC-MS).

    Measured: Baseline

  17. 1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites

    (assessed using LC-MS).

    Measured: Change from baseline at 6 months

  18. 1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites

    (assessed using LC-MS).

    Measured: Change from baseline at 12 months

  19. 1D.i.0 Intestinal Microbiome (Viruses) - Richness

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Baseline

  20. 1D.i.6 Intestinal Microbiome (Viruses) - Richness

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 6 months

  21. 1D.i.12 Intestinal Microbiome (Viruses) - Richness

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 12 months

  22. 1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Baseline

  23. 1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 6 months

  24. 1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 12 months

  25. 1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity

    Measurement of beta diversity (assessed metagenomic sequencing).

    Measured: Baseline

  26. 1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity

    Measurement of beta diversity (assessed metagenomic sequencing).

    Measured: 6 months

  27. 1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity

    Measurement of beta diversity (assessed metagenomic sequencing).

    Measured: 12 months

  28. 1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.

    ANCOM analysis (assessed metagenomic sequencing).

    Measured: Baseline

  29. 1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.

    ANCOM analysis (assessed metagenomic sequencing).

    Measured: Change from baseline at 6 months

  30. 1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.

    ANCOM analysis (assessed metagenomic sequencing).

    Measured: Change from baseline at 12 months

  31. 2A.i.0 Respiratory Microbiome (Bacteria) - Richness

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  32. 2A.i.6 Respiratory Microbiome (Bacteria) - Richness

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  33. 2A.i.12 Respiratory Microbiome (Bacteria) - Richness

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  34. 2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  35. 2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  36. 2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index

    Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  37. 2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances

    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  38. 2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances

    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  39. 2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances

    Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  40. 2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria

    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Baseline

  41. 2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria

    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 6 months

  42. 2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria

    ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).

    Measured: Change from baseline at 12 months

  43. 2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins

    (assessed using LC-MS).

    Measured: Baseline

  44. 2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins

    (assessed using LC-MS).

    Measured: Change from baseline at 6 months

  45. 2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins

    (assessed using LC-MS).

    Measured: Change from baseline at 12 months

  46. 2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites

    (assessed using LC-MS).

    Measured: Baseline

  47. 2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites

    (assessed using LC-MS).

    Measured: Change from baseline at 6 months

  48. 2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites

    (assessed using LC-MS).

    Measured: Change from baseline at 12 months

  49. 2D.i.0 Respiratory Microbiome (Viruses) - Richness

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Baseline

  50. 2D.i.6 Respiratory Microbiome (Viruses) - Richness

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 6 months

  51. 2D.i.12 Respiratory Microbiome (Viruses) - Richness

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 12 months

  52. 2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Baseline

  53. 2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 6 months

  54. 2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index

    Measurement of alpha diversity (assessed metagenomic sequencing).

    Measured: Change from baseline at 12 months

  55. 2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity

    Measurement of beta diversity (assessed metagenomic sequencing).

    Measured: Baseline

  56. 2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity

    Measurement of beta diversity (assessed metagenomic sequencing).

    Measured: 6 months

  57. 2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity

    Measurement of beta diversity (assessed metagenomic sequencing).

    Measured: 12 months

  58. 2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses

    ANCOM analysis (assessed metagenomic sequencing).

    Measured: Baseline

  59. 2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses

    ANCOM analysis (assessed metagenomic sequencing).

    Measured: Change from baseline at 6 months

  60. 2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses

    ANCOM analysis (assessed metagenomic sequencing).

    Measured: Change from baseline at 12 months

  61. 3A.i.0 Diet - total energy intake

    Kilojoules (assessed using a 24-hour recall or ACAES).

    Measured: Baseline

  62. 3A.i.6 Diet - total energy intake

    Kilojoules (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 6 months

  63. 3A.i.12 Diet - total energy intake

    Kilojoules (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 12 months

  64. 3B.i.0 Diet - percentage energy from core foods

    (assessed using a 24-hour recall or ACAES).

    Measured: Baseline

  65. 3B.i.6 Diet - percentage energy from core foods

    (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 6 months

  66. 3B.i.12 Diet - percentage energy from core foods

    (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 12 months

  67. 3C.i.0 Diet - total macronutrients intake

    Grams (assessed using a 24-hour recall or ACAES).

    Measured: Baseline

  68. 3C.i.6 Diet - total macronutrients intake

    Grams (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 6 months

  69. 3C.i.12 Diet - total macronutrients intake

    Grams (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 12 months

  70. 3C.ii.0 Diet - macronutrients proportion of total energy intake

    Percentage (assessed using a 24-hour recall or ACAES).

    Measured: Baseline

  71. 3C.ii.6 Diet - macronutrients proportion of total energy intake

    Percentage (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 6 months

  72. 3C.ii.12 Diet - macronutrients proportion of total energy intake

    Percentage (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 12 months

  73. 3D.i.0 Diet - total micronutrients intake

    Milligrams (assessed using a 24-hour recall or ACAES).

    Measured: Baseline

  74. 3D.i.6 Diet - total micronutrients intake

    Milligrams (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 6 months

  75. 3D.i.12 Diet - total micronutrients intake

    Milligrams (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 12 months

  76. 3D.ii.0 Diet - micronutrients proportion of total energy intake

    Percentage (assessed using a 24-hour recall or ACAES).

    Measured: Baseline

  77. 3D.ii.6 Diet - micronutrients proportion of total energy intake

    Percentage (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 6 months

  78. 3D.ii.12 Diet - micronutrients proportion of total energy intake

    Percentage (assessed using a 24-hour recall or ACAES).

    Measured: Change from baseline at 12 months

  79. 3E.i.0 Diet - diet quality score

    Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).

    Measured: Baseline

  80. 3E.i.6 Diet - diet quality score

    Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).

    Measured: Change from baseline at 6 months

  81. 3E.i.12 Diet - diet quality score

    Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).

    Measured: Change from baseline at 12 months

Secondary outcomes (81)

  1. 4A.i.0 Faecal biomarkers - calprotectin

    mg/kg (assessed using an ELISA).

    Measured: Baseline

  2. 4A.i.6 Faecal biomarkers - calprotectin

    mg/kg (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  3. 4A.i.12 Faecal biomarkers - calprotectin

    mg/kg (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  4. 4A.ii.0 Faecal biomarkers - M2 pyruvate kinase

    U/mL (assessed using an ELISA).

    Measured: Baseline

  5. 4A.ii.6 Faecal biomarkers - M2 pyruvate kinase

    U/mL (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  6. 4A.ii.12 Faecal biomarkers - M2 pyruvate kinase

    U/mL (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  7. 4A.iii.0 Faecal biomarkers - C-reactive protein

    mg/L (assessed using an ELISA).

    Measured: Baseline

  8. 4A.iii.6 Faecal biomarkers - C-reactive protein

    mg/L (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  9. 4A.iii.12 Faecal biomarkers - C-reactive protein

    mg/L (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  10. 4A.iv.0 Faecal biomarkers - Interleukins

    IU (assessed using an ELISA).

    Measured: Baseline

  11. 4A.iv.6 Faecal biomarkers - Interleukins

    IU (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  12. 4A.iv.12 Faecal biomarkers - Interleukins

    IU (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  13. 4B.i.0 Respiratory biomarkers - calprotectin

    mg/kg (assessed using an ELISA).

    Measured: Baseline

  14. 4B.i.6 Respiratory biomarkers - calprotectin

    mg/kg (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  15. 4B.i.12 Respiratory biomarkers - calprotectin

    mg/kg (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  16. 4B.ii.0 Respiratory biomarkers - C-reactive protein

    mg/L (assessed using an ELISA).

    Measured: Baseline

  17. 4B.ii.6 Respiratory biomarkers - C-reactive protein

    mg/L (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  18. 4B.ii.12 Respiratory biomarkers - C-reactive protein

    mg/L (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  19. 4B.iii.0 Respiratory biomarkers - Interleukins

    IU (assessed using an ELISA).

    Measured: Baseline

  20. 4B.iii.6 Respiratory biomarkers - Interleukins

    IU (assessed using an ELISA).

    Measured: Change from baseline at 6 months

  21. 4B.iii.12 Respiratory biomarkers - Interleukins

    IU (assessed using an ELISA).

    Measured: Change from baseline at 12 months

  22. 5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)

    Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.

    Measured: Baseline

  23. 5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)

    Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 6 months

  24. 5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)

    Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 12 months

  25. 5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)

    Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Baseline

  26. 5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)

    Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 6 months

  27. 5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)

    Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 12 months

  28. 5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)

    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.

    Measured: Baseline

  29. 5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)

    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.

    Measured: Change from baseline at 6 months

  30. 5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)

    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.

    Measured: Change from baseline at 12 months

  31. 5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)

    Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Baseline

  32. 5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)

    Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 6 months

  33. 5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)

    Parent report for children (ages 8-12 years) or child report (ages 8-12 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 12 months

  34. 5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)

    Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Baseline

  35. 5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)

    Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 6 months

  36. 5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)

    Parent report for teens (ages 13-18 years) or teen report (ages 13-18 years). Score out of 100, higher scores indicate better HRQOL.

    Measured: Change from baseline at 12 months

  37. 5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)

    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.

    Measured: Baseline

  38. 5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)

    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.

    Measured: 6 months

  39. 5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)

    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.

    Measured: 12 months

  40. 5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)

    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.

    Measured: Baseline

  41. 5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)

    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.

    Measured: 6 months

  42. 5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)

    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.

    Measured: 12 months

  43. 5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)

    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.

    Measured: Baseline

  44. 5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)

    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.

    Measured: 6 months

  45. 5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)

    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.

    Measured: 12 months

  46. 5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)

    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.

    Measured: Baseline

  47. 5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)

    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.

    Measured: Change from baseline at 6 months

  48. 5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)

    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.

    Measured: Change from baseline at 12 months

  49. 5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)

    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.

    Measured: Baseline

  50. 5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)

    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.

    Measured: Change from baseline at 6 months

  51. 5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)

    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.

    Measured: Change from baseline at 12 months

  52. 5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)

    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.

    Measured: Baseline

  53. 5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)

    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.

    Measured: Change from baseline at 6 months

  54. 5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)

    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.

    Measured: Change from baseline at 12 months

  55. 5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).

    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.

    Measured: Baseline

  56. 5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).

    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.

    Measured: Change from baseline at 6 months

  57. 5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).

    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.

    Measured: Change from baseline at 12 months

  58. 5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).

    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.

    Measured: Baseline

  59. 5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).

    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.

    Measured: Change from baseline at 6 months

  60. 5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).

    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.

    Measured: Change from baseline at 12 months

  61. 6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)

    Z-score.

    Measured: Baseline

  62. 6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)

    Z-score.

    Measured: Change from baseline at 6 months

  63. 6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)

    Z-score.

    Measured: Change from baseline at 12 months

  64. 6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)

    Z-score.

    Measured: Baseline

  65. 6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)

    Z-score.

    Measured: Change from baseline at 6 months

  66. 6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)

    Z-score.

    Measured: Change from baseline at 12 months

  67. 6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)

    Z-score.

    Measured: Baseline

  68. 6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)

    Z-score.

    Measured: Change from baseline at 6 months

  69. 6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)

    Z-score.

    Measured: Change from baseline at 12 months

  70. 6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)

    Z-score.

    Measured: Baseline

  71. 6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)

    Z-score.

    Measured: Change from baseline at 6 months

  72. 6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)

    Z-score.

    Measured: Change from baseline at 12 months

  73. 6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)

    Z-score.

    Measured: Baseline

  74. 6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)

    Z-score.

    Measured: Change from baseline at 6 months

  75. 6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)

    Z-score.

    Measured: Change from baseline at 12 months

  76. 6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations

    During period from baseline to 6 months.

    Measured: 6 months

  77. 6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations

    During period from baseline to 12 months.

    Measured: 12 months

  78. 6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations

    Days hospitalised during period from baseline to 6 months.

    Measured: 6 months

  79. 6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations

    Days hospitalised during period from baseline to 12 months.

    Measured: 12 months

  80. 6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations

    During period from baseline to 6 months.

    Measured: 6 months

  81. 6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations

    During period from baseline to 12 months.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start18 Apr 2018
  3. Primary completion13 Mar 2023 (estimated)
  4. Study completion13 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04071314
Sponsor's protocol ID
HREC/18/SCHN/26
Acronym
EARTH
Status last verified
Aug 2019
First submitted
21 Aug 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data and biological samples may be utilised by study investigators ONLY for the sole purpose of a research project.

Publications

  • McKay I, van Dorst J, Katz T, Doumit M, Prentice B, Owens L, Belessis Y, Chuang S, Jaffe A, Thomas T, Coffey M, Ooi CY. Diet and the gut-lung axis in cystic fibrosis - direct & indirect links. Gut Microbes. 2023 Jan-Dec;15(1):2156254. doi: 10.1080/19490976.2022.2156254.

    PubMed 36573804

  • 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.

    PubMed 35653431

  • 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.

    PubMed 32295774

Questions about this trial

What is this clinical trial studying?

An observational study of Cystic Fibrosis and Hirschprung's Disease, run by The University of New South Wales at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael J Coffey (61293825574, michael.coffey@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1A.i.0 Intestinal Microbiome (Bacteria) - Richness (time frame: Baseline). The study lists 81 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04071314, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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