Recruiting

The Gut-Lung Axis and Respiratory Illness in Children

ClinicalTrials.gov IDNCT06271213

PhaseNot Applicable

Enrollment150

SponsorNHS Greater Glasgow and Clyde

Age0 Years

SexALL

I'm interested View official listing

Conditions studied

Respiration Disorders, Respiratory Disease, Asthma in Children, Wheezing, Gastro-Intestinal Disorder, Healthy

About this study

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.

Interventions

Other: observational only - no interventions as part of study — 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.

Primary outcomes

Assess differences in gut and lung microbiota diversity between groups (At admission on a single day)
Assess changes in gut and lung microbiota in children with asthma receiving biologics (Measurement 1 at baseline. Measurement 2 anywhere from 8-52 weeks.)
Determine mediators of gut-lung axis in health and disease (At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.)

Eligibility information

Inclusion Criteria: * 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). * Any child admitted to RHC with asthma/wheeze not indicated for biologic therapy (asthma control group). Exclusion Criteria: * 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. * Any child with Asthma currently receiving Biologics therapy (unless recruited via bronchoscopy route).

Study locations

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

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.