The Gut-Lung Axis and Respiratory Illness in Children

NCT06271213 | Recruiting

• 1 other identifier: 303841
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiration Disorders; Respiratory Disease; Asthma in Children; Wheezing; Gastro-Intestinal Disorder; Healthy

Keywords

Gut-Lung Axis; Microbiome; Multi-omics; Children

Outcome Measures

Primary Outcomes (3)

• Assess differences in gut and lung microbiota diversity between groups

  Beta diversity: measure the differences in species composition between different ecosystems. Are there statistically significant differences in beta-diversity (p\<0.05 between the gut and airway microbiome of cohorts)

  At admission on a single day

• Assess changes in gut and lung microbiota in children with asthma receiving biologics

  Alpha diversity: measure of species richness and evenness within a sample. Are there statistically significant (p\<0.05) differences in species richness and evenness at sampled anatomical sites between cohorts.

  Measurement 1 at baseline. Measurement 2 anywhere from 8-52 weeks.

• Determine mediators of gut-lung axis in health and disease

  Are there statistically significant differences (p\<0.05) in immunological/nutritional/metabolic/transcriptional factors in health and disease

  At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.

Secondary Outcomes (2)

• Nutritional influence in gut-lung axis

  approximately up to 12 weeks before to 12-weeks after admission.

• Multi-omics integration

  At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.

Study Arms (5)

Respiratory Disease

Children with respiratory complications receiving general anaesthesia undergoing bronchoscopy

Other: observational only - no interventions as part of study

Gastrointestinal Disease

Children with G.I. complications receiving general anaesthesia undergoing endoscopy

Other: observational only - no interventions as part of study

Orthopaedic controls

Children with orthopaedic issue receiving general anaesthesia undergoing orthopaedic correction

Other: observational only - no interventions as part of study

Asthma Control

Children with Asthma/wheeze not indicated for biologics therapy

Other: observational only - no interventions as part of study

Asthma Treatment

Children with Asthma/wheeze indicated for biologics therapy

Other: observational only - no interventions as part of study

Interventions

observational only - no interventions as part of study OTHER

Children with asthma will be receiving biologics therapy as part of their standard of care - unrelated to this study design. All cohorts will be observed without study intervention.

Asthma Control; Asthma Treatment; Gastrointestinal Disease; Orthopaedic controls; Respiratory Disease

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children attending Royal Hospital for Children, Glasgow receiving general anaesthesia for bronchoscopy, endoscopy or orthopaedic procedures. Children attending Royal Hospital for Children for routine procedures with asthma/wheeze.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow

Glasgow, United Kingdom

RECRUITING

Biospecimen

Nasopharyngeal swabs immunological/metabolic/microbiome analyses Lower airway Samples for immunological/metabolic/microbiome analyses stool samples for immunological/metabolic/microbiome analyses blood samples for for immunological/metabolic analyses

MeSH Terms

Conditions

Respiration Disorders; Respiratory Sounds; Digestive System Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ross J Langley, MRCPCH

  NHS Greater Glasgow and Clyde Board HQ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross J Langley, MRCPCH

CONTACT

0141 451 6683; ross.langley@ggc.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 21, 2024
• Study Start: February 4, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

GB (1)