NCT06271213Recruiting
The Gut-Lung Axis and Respiratory Illness in Children
Source: ClinicalTrials.gov · Last updated 21 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 30 Jan 2024
- Start date
- 4 Feb 2024
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Diseases
- Asthma
- NCT number
- NCT06271213
What you commit to
- Study type: Observational
- Planned participants: 150
- From 4 Feb 2024 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics by the day of admission or have used antibiotics in the previous month (unless prophylactic antibiotics \> 1 month use).
- Any child with Asthma currently receiving Biologics therapy (unless recruited via bronchoscopy route).
Other illness
- Any child known to be infected with, or at high risk of having had exposure to HIV, hepatitis B or hepatitis C viruses
Age
- Any person 17 years old and above.
Other
- . Any child and/or parent/guardian who cannot understand the English language where consent would be unethical.
Who the study is looking for
- 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).
Age in the registry: 0 years to 16 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.