Actively Recruiting

Age: 0Years - 16Years
All Genders
Healthy Volunteers
NCT06271213

The Gut-Lung Axis and Respiratory Illness in Children

Led by NHS Greater Glasgow and Clyde · Updated on 2024-02-21

150

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

N

NHS Greater Glasgow and Clyde

Lead Sponsor

U

University of Glasgow

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease. Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are: * What does a healthy gut-lung axis look like? * Do children with respiratory issues show an altered gut microbiome? * Do children with GI issues show an altered lung microbiome? Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control). Participants will provide: * airway samples (to investigate the lung microbiome) * blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care * stool samples (to assess gut microbiome) * dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis.

CONDITIONS

Official Title

The Gut-Lung Axis and Respiratory Illness in Children

Who Can Participate

Age: 0Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any infant, child, or young person admitted for elective bronchoscopy or gastrointestinal endoscopy
  • Any infant or child attending for emergency or elective orthopedic surgery without active respiratory or gastrointestinal conditions
  • Any child attending the respiratory department who can produce sputum and will have a blood sample taken as part of standard care
  • Any infant, child, or young person admitted for clinical asthma or wheeze care before starting biologics therapy (treatment group)
  • Any child with asthma or wheeze not indicated for biologic therapy (asthma control group)
Not Eligible

You will not qualify if you...

  • Use of antibiotics on the day of admission or within the previous month (except prophylactic antibiotics used for more than 1 month)
  • Age 17 years or older
  • Known infection with or high risk of exposure to HIV, hepatitis B, or hepatitis C
  • Inability of child or parent/guardian to understand English such that informed consent is not possible
  • Child currently receiving biologics therapy for asthma unless recruited through bronchoscopy route

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow

Glasgow, United Kingdom

Actively Recruiting

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Research Team

R

Ross J Langley, MRCPCH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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