NCT06271213 The Gut-Lung Axis and Respiratory Illness in Children
| NCT ID | NCT06271213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NHS Greater Glasgow and Clyde |
| Condition | Respiration Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-02-04 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-02-04 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Ross J Langley, MRCPCH
PRINCIPAL INVESTIGATOR
NHS Greater Glasgow and Clyde Board HQ
Frequently Asked Questions
Who can join the NCT06271213 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 16 Years, studying Respiration Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06271213 currently recruiting?
Yes, NCT06271213 is actively recruiting participants. Contact the research team at ross.langley@ggc.scot.nhs.uk for enrollment information.
Where is the NCT06271213 trial being conducted?
This trial is being conducted at Glasgow, United Kingdom.
Who is sponsoring the NCT06271213 clinical trial?
NCT06271213 is sponsored by NHS Greater Glasgow and Clyde. The principal investigator is Ross J Langley, MRCPCH at NHS Greater Glasgow and Clyde Board HQ. The trial plans to enroll 150 participants.