Investigating the connection between gut and lung health in children
The Gut-Lung Axis and Respiratory Illness in Children
This study is trying to see how gut health affects lung health in children with breathing or stomach problems compared to those who are healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 0 Years to 16 Years |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 1 site (Glasgow) |
| Trial ID | NCT06271213 on ClinicalTrials.gov |
What this trial studies
This observational study at the Royal Hospital for Children in Glasgow aims to explore the gut-lung axis in children with respiratory and gastrointestinal conditions using a multi-omics approach. It consists of two parts: a cross-sectional analysis comparing the gut and lung microbiomes of children with respiratory or GI issues to those without, and a longitudinal assessment of the effects of biologics on the gut-lung axis in children with asthma. The study seeks to establish correlations and validate the bidirectional relationship between gut and lung microbiomes in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates include children aged 0-16 with respiratory or gastrointestinal conditions, as well as healthy children attending for orthopedic care.
Not a fit: Patients over 16 years old or those who have recently used antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of respiratory illnesses in children by targeting the gut-lung axis.
How similar studies have performed: While pre-clinical evidence exists regarding the gut-lung axis, clinical studies specifically in pediatric populations are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Glasgow
- NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow — Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ross J Langley, MRCPCH — NHS Greater Glasgow and Clyde Board HQ
- Study coordinator: Ross J Langley, MRCPCH
- Email: ross.langley@ggc.scot.nhs.uk
- Phone: 0141 451 6683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.