The Gut-Lung Axis and Respiratory Illness in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-16
SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any infant/child/young person admitted to the RHC, Glasgow for an elective bronchoscopy or GI endoscopy.

Any infant/child attending for an emergency/elective orthopaedic operation without active respiratory or gastrointestinal conditions or receiving treatment for either condition. (Age range birth to 16 years for all groups recruited).

Any child attending respiratory department at RHC who can induce sputum and is having a blood sample taken, with latter part of standard of care.

Any infant/child/young person admitted to RHC for a clinical care appointment with Asthma/wheeze before commencement of biologics therapy (treatment group).

Disqualifiers

Use of antibiotics by the day of admission or have used antibiotics in the previous month (unless prophylactic antibiotics > 1 month use).

Any person 17 years old and above.

Any child known to be infected with, or at high risk of having had exposure to HIV, hepatitis B or hepatitis C viruses

. Any child and/or parent/guardian who cannot understand the English language where consent would be unethical.

Trial population

Children attending Royal Hospital for Children, Glasgow receiving general anaesthesia for bronchoscopy, endoscopy or orthopaedic procedures. Children attending Royal Hospital for Children for routine procedures with asthma/wheeze.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • observational only - no interventions as part of study

    Other intervention

    Children with asthma will be receiving biologics therapy as part of their standard of care - unrelated to this study design. All cohorts will be observed without study intervention.

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Respiratory Disease1 intervention
Group B: Gastrointestinal Disease1 intervention
Group C: Orthopaedic controls1 intervention
Group D: Asthma Control1 intervention
Group E: Asthma Treatment1 intervention

Trial outcomes

Primary outcomes

1

Assess differences in gut and lung microbiota diversity between groups

Beta diversity: measure the differences in species composition between different ecosystems. Are there statistically significant differences in beta-diversity (p\<0.05 between the gut and airway microbiome of cohorts)

Time frame
At admission on a single day
2

Assess changes in gut and lung microbiota in children with asthma receiving biologics

Alpha diversity: measure of species richness and evenness within a sample. Are there statistically significant (p\<0.05) differences in species richness and evenness at sampled anatomical sites between cohorts.

Time frame
Measurement 1 at baseline. Measurement 2 anywhere from 8-52 weeks.
3

Determine mediators of gut-lung axis in health and disease

Are there statistically significant differences (p\<0.05) in immunological/nutritional/metabolic/transcriptional factors in health and disease

Time frame
At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.

Secondary outcomes

1

Nutritional influence in gut-lung axis

Correlations between dietary factors (assessed via dietary questionnaires and/or food diary) on the gut-lung axis.

Time frame
approximately up to 12 weeks before to 12-weeks after admission.
2

Multi-omics integration

Can a multi-omics view enhance our understanding of the gut-lung axis by integrating microbiome, immunological and nutritional/metabolic data.

Time frame
At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Glasgow

Collaborator