Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

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

2019. augusztus 24. frissítette: Dr Michael Coffey, The University of New South Wales

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Várható)

72

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Ausztrália
    • New South Wales
      • Randwick, New South Wales, Ausztrália, 2031
        • Toborzás
        • Sydney Children's Hospital
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

Nem régebbi, mint 18 év (Gyermek, Felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
1A.i.0 Intestinal Microbiome (Bacteria) - Richness
Időkeret: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
Időkeret: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Időkeret: Baseline
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Időkeret: 6 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
6 months
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
Időkeret: 12 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
12 months
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Időkeret: Baseline
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Időkeret: Change from baseline at 6 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
Időkeret: Change from baseline at 12 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Időkeret: Baseline
(assessed using LC-MS).
Baseline
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Időkeret: Change from baseline at 6 months
(assessed using LC-MS).
Change from baseline at 6 months
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
Időkeret: Change from baseline at 12 months
(assessed using LC-MS).
Change from baseline at 12 months
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Időkeret: Baseline
(assessed using LC-MS).
Baseline
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Időkeret: Change from baseline at 6 months
(assessed using LC-MS).
Change from baseline at 6 months
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
Időkeret: Change from baseline at 12 months
(assessed using LC-MS).
Change from baseline at 12 months
1D.i.0 Intestinal Microbiome (Viruses) - Richness
Időkeret: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
Baseline
1D.i.6 Intestinal Microbiome (Viruses) - Richness
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 6 months
1D.i.12 Intestinal Microbiome (Viruses) - Richness
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 12 months
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
Időkeret: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
Baseline
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 6 months
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 12 months
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Időkeret: Baseline
Measurement of beta diversity (assessed metagenomic sequencing).
Baseline
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Időkeret: 6 months
Measurement of beta diversity (assessed metagenomic sequencing).
6 months
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
Időkeret: 12 months
Measurement of beta diversity (assessed metagenomic sequencing).
12 months
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Időkeret: Baseline
ANCOM analysis (assessed metagenomic sequencing).
Baseline
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Időkeret: Change from baseline at 6 months
ANCOM analysis (assessed metagenomic sequencing).
Change from baseline at 6 months
1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
Időkeret: Change from baseline at 12 months
ANCOM analysis (assessed metagenomic sequencing).
Change from baseline at 12 months
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
Időkeret: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
Időkeret: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Időkeret: Baseline
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Időkeret: Change from baseline at 6 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
Időkeret: Change from baseline at 12 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Időkeret: Baseline
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Baseline
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Időkeret: Change from baseline at 6 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 6 months
2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
Időkeret: Change from baseline at 12 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
Change from baseline at 12 months
2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Időkeret: Baseline
(assessed using LC-MS).
Baseline
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Időkeret: Change from baseline at 6 months
(assessed using LC-MS).
Change from baseline at 6 months
2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
Időkeret: Change from baseline at 12 months
(assessed using LC-MS).
Change from baseline at 12 months
2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Időkeret: Baseline
(assessed using LC-MS).
Baseline
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Időkeret: Change from baseline at 6 months
(assessed using LC-MS).
Change from baseline at 6 months
2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
Időkeret: Change from baseline at 12 months
(assessed using LC-MS).
Change from baseline at 12 months
2D.i.0 Respiratory Microbiome (Viruses) - Richness
Időkeret: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
Baseline
2D.i.6 Respiratory Microbiome (Viruses) - Richness
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 6 months
2D.i.12 Respiratory Microbiome (Viruses) - Richness
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 12 months
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
Időkeret: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
Baseline
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
Időkeret: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 6 months
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
Időkeret: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
Change from baseline at 12 months
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Időkeret: Baseline
Measurement of beta diversity (assessed metagenomic sequencing).
Baseline
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Időkeret: 6 months
Measurement of beta diversity (assessed metagenomic sequencing).
6 months
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
Időkeret: 12 months
Measurement of beta diversity (assessed metagenomic sequencing).
12 months
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
Időkeret: Baseline
ANCOM analysis (assessed metagenomic sequencing).
Baseline
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
Időkeret: Change from baseline at 6 months
ANCOM analysis (assessed metagenomic sequencing).
Change from baseline at 6 months
2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
Időkeret: Change from baseline at 12 months
ANCOM analysis (assessed metagenomic sequencing).
Change from baseline at 12 months
3A.i.0 Diet - total energy intake
Időkeret: Baseline
Kilojoules (assessed using a 24-hour recall or ACAES).
Baseline
3A.i.6 Diet - total energy intake
Időkeret: Change from baseline at 6 months
Kilojoules (assessed using a 24-hour recall or ACAES).
Change from baseline at 6 months
3A.i.12 Diet - total energy intake
Időkeret: Change from baseline at 12 months
Kilojoules (assessed using a 24-hour recall or ACAES).
Change from baseline at 12 months
3B.i.0 Diet - percentage energy from core foods
Időkeret: Baseline
(assessed using a 24-hour recall or ACAES).
Baseline
3B.i.6 Diet - percentage energy from core foods
Időkeret: Change from baseline at 6 months
(assessed using a 24-hour recall or ACAES).
Change from baseline at 6 months
3B.i.12 Diet - percentage energy from core foods
Időkeret: Change from baseline at 12 months
(assessed using a 24-hour recall or ACAES).
Change from baseline at 12 months
3C.i.0 Diet - total macronutrients intake
Időkeret: Baseline
Grams (assessed using a 24-hour recall or ACAES).
Baseline
3C.i.6 Diet - total macronutrients intake
Időkeret: Change from baseline at 6 months
Grams (assessed using a 24-hour recall or ACAES).
Change from baseline at 6 months
3C.i.12 Diet - total macronutrients intake
Időkeret: Change from baseline at 12 months
Grams (assessed using a 24-hour recall or ACAES).
Change from baseline at 12 months
3C.ii.0 Diet - macronutrients proportion of total energy intake
Időkeret: Baseline
Percentage (assessed using a 24-hour recall or ACAES).
Baseline
3C.ii.6 Diet - macronutrients proportion of total energy intake
Időkeret: Change from baseline at 6 months
Percentage (assessed using a 24-hour recall or ACAES).
Change from baseline at 6 months
3C.ii.12 Diet - macronutrients proportion of total energy intake
Időkeret: Change from baseline at 12 months
Percentage (assessed using a 24-hour recall or ACAES).
Change from baseline at 12 months
3D.i.0 Diet - total micronutrients intake
Időkeret: Baseline
Milligrams (assessed using a 24-hour recall or ACAES).
Baseline
3D.i.6 Diet - total micronutrients intake
Időkeret: Change from baseline at 6 months
Milligrams (assessed using a 24-hour recall or ACAES).
Change from baseline at 6 months
3D.i.12 Diet - total micronutrients intake
Időkeret: Change from baseline at 12 months
Milligrams (assessed using a 24-hour recall or ACAES).
Change from baseline at 12 months
3D.ii.0 Diet - micronutrients proportion of total energy intake
Időkeret: Baseline
Percentage (assessed using a 24-hour recall or ACAES).
Baseline
3D.ii.6 Diet - micronutrients proportion of total energy intake
Időkeret: Change from baseline at 6 months
Percentage (assessed using a 24-hour recall or ACAES).
Change from baseline at 6 months
3D.ii.12 Diet - micronutrients proportion of total energy intake
Időkeret: Change from baseline at 12 months
Percentage (assessed using a 24-hour recall or ACAES).
Change from baseline at 12 months
3E.i.0 Diet - diet quality score
Időkeret: Baseline
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Baseline
3E.i.6 Diet - diet quality score
Időkeret: Change from baseline at 6 months
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Change from baseline at 6 months
3E.i.12 Diet - diet quality score
Időkeret: Change from baseline at 12 months
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
Change from baseline at 12 months

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
4A.i.0 Faecal biomarkers - calprotectin
Időkeret: Baseline
mg/kg (assessed using an ELISA).
Baseline
4A.i.6 Faecal biomarkers - calprotectin
Időkeret: Change from baseline at 6 months
mg/kg (assessed using an ELISA).
Change from baseline at 6 months
4A.i.12 Faecal biomarkers - calprotectin
Időkeret: Change from baseline at 12 months
mg/kg (assessed using an ELISA).
Change from baseline at 12 months
4A.ii.0 Faecal biomarkers - M2 pyruvate kinase
Időkeret: Baseline
U/mL (assessed using an ELISA).
Baseline
4A.ii.6 Faecal biomarkers - M2 pyruvate kinase
Időkeret: Change from baseline at 6 months
U/mL (assessed using an ELISA).
Change from baseline at 6 months
4A.ii.12 Faecal biomarkers - M2 pyruvate kinase
Időkeret: Change from baseline at 12 months
U/mL (assessed using an ELISA).
Change from baseline at 12 months
4A.iii.0 Faecal biomarkers - C-reactive protein
Időkeret: Baseline
mg/L (assessed using an ELISA).
Baseline
4A.iii.6 Faecal biomarkers - C-reactive protein
Időkeret: Change from baseline at 6 months
mg/L (assessed using an ELISA).
Change from baseline at 6 months
4A.iii.12 Faecal biomarkers - C-reactive protein
Időkeret: Change from baseline at 12 months
mg/L (assessed using an ELISA).
Change from baseline at 12 months
4A.iv.0 Faecal biomarkers - Interleukins
Időkeret: Baseline
IU (assessed using an ELISA).
Baseline
4A.iv.6 Faecal biomarkers - Interleukins
Időkeret: Change from baseline at 6 months
IU (assessed using an ELISA).
Change from baseline at 6 months
4A.iv.12 Faecal biomarkers - Interleukins
Időkeret: Change from baseline at 12 months
IU (assessed using an ELISA).
Change from baseline at 12 months
4B.i.0 Respiratory biomarkers - calprotectin
Időkeret: Baseline
mg/kg (assessed using an ELISA).
Baseline
4B.i.6 Respiratory biomarkers - calprotectin
Időkeret: Change from baseline at 6 months
mg/kg (assessed using an ELISA).
Change from baseline at 6 months
4B.i.12 Respiratory biomarkers - calprotectin
Időkeret: Change from baseline at 12 months
mg/kg (assessed using an ELISA).
Change from baseline at 12 months
4B.ii.0 Respiratory biomarkers - C-reactive protein
Időkeret: Baseline
mg/L (assessed using an ELISA).
Baseline
4B.ii.6 Respiratory biomarkers - C-reactive protein
Időkeret: Change from baseline at 6 months
mg/L (assessed using an ELISA).
Change from baseline at 6 months
4B.ii.12 Respiratory biomarkers - C-reactive protein
Időkeret: Change from baseline at 12 months
mg/L (assessed using an ELISA).
Change from baseline at 12 months
4B.iii.0 Respiratory biomarkers - Interleukins
Időkeret: Baseline
IU (assessed using an ELISA).
Baseline
4B.iii.6 Respiratory biomarkers - Interleukins
Időkeret: Change from baseline at 6 months
IU (assessed using an ELISA).
Change from baseline at 6 months
4B.iii.12 Respiratory biomarkers - Interleukins
Időkeret: Change from baseline at 12 months
IU (assessed using an ELISA).
Change from baseline at 12 months
5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Időkeret: Baseline
Parent report for infants (ages 1-12 months) or (ages 13-24 months). Score out of 100, higher scores indicate better HRQOL.
Baseline
5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Időkeret: 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.
Change from baseline at 6 months
5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
Időkeret: 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.
Change from baseline at 12 months
5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Időkeret: Baseline
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Baseline
5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Időkeret: Change from baseline at 6 months
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Change from baseline at 6 months
5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
Időkeret: Change from baseline at 12 months
Parent report for toddlers (ages 2-4 years). Score out of 100, higher scores indicate better HRQOL.
Change from baseline at 12 months
5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Időkeret: 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.
Baseline
5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Időkeret: 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.
Change from baseline at 6 months
5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
Időkeret: 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.
Change from baseline at 12 months
5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Időkeret: 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.
Baseline
5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Időkeret: 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.
Change from baseline at 6 months
5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
Időkeret: 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.
Change from baseline at 12 months
5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Időkeret: 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.
Baseline
5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Időkeret: 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.
Change from baseline at 6 months
5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
Időkeret: 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.
Change from baseline at 12 months
5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Időkeret: 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.
Baseline
5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Időkeret: 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.
6 months
5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
Időkeret: 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.
12 months
5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
Időkeret: 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.
Baseline
5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
Időkeret: 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.
6 months
5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
Időkeret: 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.
12 months
5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
Időkeret: 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.
Baseline
5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
Időkeret: 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.
6 months
5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
Időkeret: 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.
12 months
5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
Időkeret: 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.
Baseline
5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
Időkeret: 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.
Change from baseline at 6 months
5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
Időkeret: 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.
Change from baseline at 12 months
5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Időkeret: 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.
Baseline
5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Időkeret: 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.
Change from baseline at 6 months
5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
Időkeret: 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.
Change from baseline at 12 months
5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Időkeret: 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.
Baseline
5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Időkeret: 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.
Change from baseline at 6 months
5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
Időkeret: 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.
Change from baseline at 12 months
5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Időkeret: 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.
Baseline
5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Időkeret: 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.
Change from baseline at 6 months
5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
Időkeret: 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.
Change from baseline at 12 months
5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Időkeret: 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.
Baseline
5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Időkeret: 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.
Change from baseline at 6 months
5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
Időkeret: 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.
Change from baseline at 12 months
6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Időkeret: Baseline
Z-score.
Baseline
6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Időkeret: Change from baseline at 6 months
Z-score.
Change from baseline at 6 months
6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
Időkeret: Change from baseline at 12 months
Z-score.
Change from baseline at 12 months
6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Időkeret: Baseline
Z-score.
Baseline
6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Időkeret: Change from baseline at 6 months
Z-score.
Change from baseline at 6 months
6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
Időkeret: Change from baseline at 12 months
Z-score.
Change from baseline at 12 months
6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Időkeret: Baseline
Z-score.
Baseline
6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Időkeret: Change from baseline at 6 months
Z-score.
Change from baseline at 6 months
6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
Időkeret: Change from baseline at 12 months
Z-score.
Change from baseline at 12 months
6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Időkeret: Baseline
Z-score.
Baseline
6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Időkeret: Change from baseline at 6 months
Z-score.
Change from baseline at 6 months
6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
Időkeret: Change from baseline at 12 months
Z-score.
Change from baseline at 12 months
6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Időkeret: Baseline
Z-score.
Baseline
6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Időkeret: Change from baseline at 6 months
Z-score.
Change from baseline at 6 months
6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
Időkeret: Change from baseline at 12 months
Z-score.
Change from baseline at 12 months
6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
Időkeret: 6 months
During period from baseline to 6 months.
6 months
6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
Időkeret: 12 months
During period from baseline to 12 months.
12 months
6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
Időkeret: 6 months
Days hospitalised during period from baseline to 6 months.
6 months
6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
Időkeret: 12 months
Days hospitalised during period from baseline to 12 months.
12 months
6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
Időkeret: 6 months
During period from baseline to 6 months.
6 months
6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
Időkeret: 12 months
During period from baseline to 12 months.
12 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

The University of New South Wales

Nyomozók

  • Kutatásvezető: Michael J Coffey, University of New South Wales
  • Kutatásvezető: Chee (Keith) Y Ooi, University of New South Wales

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2018. április 18.

Elsődleges befejezés (Várható)

2023. március 13.

A tanulmány befejezése (Várható)

2023. március 13.

Tanulmányi regisztráció dátumai

Először benyújtva

2019. augusztus 21.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2019. augusztus 24.

Első közzététel (Tényleges)

2019. augusztus 28.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2019. augusztus 28.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2019. augusztus 24.

Utolsó ellenőrzés

2019. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • HREC/18/SCHN/26

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

De-identified data and biological samples may be utilised by study investigators ONLY for the sole purpose of a research project.

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Egészséges

Keressen hasonló próbaverziókban

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

CROs by country

CROs in Hong Kong

Körülmények

Ritka betegségek

Kábítószer-beavatkozások

Táplálék-kiegészítők

Szponzor / közreműködők

Helyek

3
Iratkozz fel