Actively Recruiting
The Gut-Lung Axis and Respiratory Illness in Children
Led by NHS Greater Glasgow and Clyde · Updated on 2024-02-21
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
NHS Greater Glasgow and Clyde
Lead Sponsor
U
University of Glasgow
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the gut-lung axis, a two-way connection between the gut and lung microbiomes, in children with respiratory or gastrointestinal conditions. This study focuses on children aged 0 to 16 years at the Royal Hospital for Children in Glasgow, Scotland. The aim is to understand what a healthy gut-lung axis looks like, how respiratory or GI diseases affect these microbiomes, and whether biologics therapy for asthma changes this interaction. The study is observational and involves children with respiratory disease, gastrointestinal disease, orthopedic conditions, and asthma. The study has two parts: Part A is cross-sectional, comparing children with respiratory or GI issues to those undergoing orthopedic care without such problems. Samples collected include airway, blood, and stool samples, alongside dietary information through food diaries and questionnaires. Part B is longitudinal, focusing on children with asthma who are either starting biologics therapy or not, with samples collected at baseline and again 8 to 52 weeks later. This part aims to see if biologics affect the gut-lung axis. Participants will provide airway, blood, and stool samples during procedures under general anesthesia or clinical appointments, depending on their group. Researchers will analyze microbiota diversity and mediators of the gut-lung axis, as well as nutritional influences. Dietary data, clinical information, and health questionnaires will be collected to understand the relationship between diet and the gut-lung axis. The study will monitor these factors over time, especially in children receiving biologics therapy for asthma.
CONDITIONS
Brief Title
The Gut-Lung Axis and Respiratory Illness in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any infant, child, or young person admitted for elective bronchoscopy or GI endoscopy
- Any infant, child, or young person attending for emergency or elective orthopaedic operation without active respiratory or gastrointestinal conditions
- Any child attending respiratory department who can produce sputum and is having blood taken as part of standard care
- Any infant, child, or young person admitted for clinical care with asthma or wheeze before starting biologics therapy
- Any child with asthma or wheeze not indicated for biologic therapy
You will not qualify if you...
- Use of antibiotics on admission day or within the previous month, except for prophylactic use over one month ago
- Any person aged 17 years or older
- Any child known or at high risk of exposure to HIV, hepatitis B, or hepatitis C viruses
- Any child or parent/guardian unable to understand English where consent would be unethical
- Any child with asthma currently receiving biologics therapy, unless recruited via bronchoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo collection of biological samples and clinical data to investigate the gut and lung microbiomes, blood markers, dietary intake, and clinical questionnaires.
1 visit (in-person)
Duration - 8 to 52 weeks
Participants with asthma receiving biologics therapy are observed over time to assess changes in the gut-lung axis before and after starting therapy, compared to those not receiving biologics.
2 visits (in-person) at baseline and follow-up
Trial Site Locations
Total: 1 location
1
NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow
Glasgow, United Kingdom
Actively Recruiting
Research Team
R
Ross J Langley, MRCPCH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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