protocolSection identificationModule nctId: NCT06271213, orgStudyIdInfo id: 303841, briefTitle: The Gut-Lung Axis and Respiratory Illness in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2027-11-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: NHS Greater Glasgow and Clyde, class: OTHER, collaborators name: University of Glasgow, descriptionModule briefSummary: 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., conditionsModule conditions: Respiration Disorders, conditions: Respiratory Disease, conditions: Asthma in Children, conditions: Wheezing, conditions: Gastro-Intestinal Disorder, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: observational only - no interventions as part of study, outcomesModule primaryOutcomes measure: Assess differences in gut and lung microbiota diversity between groups, primaryOutcomes measure: Assess changes in gut and lung microbiota in children with asthma receiving biologics, primaryOutcomes measure: Determine mediators of gut-lung axis in health and disease, secondaryOutcomes measure: Nutritional influence in gut-lung axis, secondaryOutcomes measure: Multi-omics integration, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow, status: RECRUITING, city: Glasgow, country: United Kingdom, contacts name: Ross J Langley, MRCPCH, role: CONTACT, phone: 0141 451 6683, email: ross.langley@ggc.scot.nhs.uk, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False