The Gut-Lung Axis and Respiratory Illness in Children (NCT06271213) | Clinical Trial Compass
RecruitingNot Applicable
The Gut-Lung Axis and Respiratory Illness in Children
United Kingdom150 participantsStarted 2024-02-04
Plain-language 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.
Who can participate
Age range
0 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess differences in gut and lung microbiota diversity between groups
Timeframe: At admission on a single day
2
Assess changes in gut and lung microbiota in children with asthma receiving biologics
Timeframe: Measurement 1 at baseline. Measurement 2 anywhere from 8-52 weeks.
3
Determine mediators of gut-lung axis in health and disease
Timeframe: At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.