Respiration DisordersNCT06271213
The Gut-Lung Axis and Respiratory Illness in Children
An observational study of Respiration Disorders and Respiratory Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiration Disorders, Respiratory Disease, Asthma in Children
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2024to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow
Glasgow
Ross J Langley, MRCPCH, 0141 451 6683, ross.langley@ggc.scot.nhs.uk
About this study
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:
Read more
- 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.
Read the detailed description
The gut-lung axis is a postulated bi-directional connection between the gut and lung microbiomes where changes at one site can induce changes in another. Although pre-clinical evidence exists, the clinical evidence, particularly in paediatric patients is currently lacking. Changes in the gut microbiome in young children have been noted prior to asthma development although concomitant investigations into the gut and lungs have not yet been made in children with asthma. Furthermore, a causal relationship between IBD and respiratory disease has recently been noted. Associations have also been made between early-life environmental factors such as the protective effects of breastfeeding on respiratory health which hints at connections between dietary intake and respiratory health, possibly via the gut-lung axis. The investigators aim to investigate the gut-lung axis in children via a multi-omics approach.
Part A (cross-sectional): The investigators aim to investigate correlations between the gut and lung microbiome in 3 cohorts of children aged 0-16 attending the Royal Hospital for Children in Glasgow: Respiratory patients, GI patients and Orthopaedic patients. Although this is a hypothesis-generating study, the investigators would like to validate this bi-directional link between the gut and the lung microbiomes. The investigators hypothesise that children with respiratory disease should have a disturbed gut microbiome and children with GI disease should present with a disturbed respiratory microbiome (assessed ecologically and functionally via metabolic and molecular biology analyses). Children receiving orthopaedic procedures without active signs of respiratory or GI issues will serve as the benchmark of a healthy 'gut-lung axis'. The investigators will also aim to investigate potential mechanisms of communication between the gut and lungs in blood via immunological, metabolic, and molecular analyses. Dietary analysis, relevant clinical data and a health questionnaire will be completed by children. Additionally, a 3-day estimated weighed food diary will be completed by the participants and a validated Food Frequency Questionnaire (FFQ) in children aged 3 and above will be used to correlate dietary intake to biological date obtained relating to the gut-lung axis.
Part B (longitudinal): Investigating the Gut-Lung axis in asthma pre and post biologics therapy. The investigators aim to investigate connections between the airway and gut-microbiome, blood and responsiveness to patients receiving biologics therapy (as part of their standard of care). Two cohorts of children will be recruited: children with asthma/wheeze not indicated for biologics and children with asthma/wheeze indicated for biologics. The investigators aim to assess whether biologics modulate the gut-lung axis by sampling airways, stool and blood from children at two time points (before and after starting therapy, compared to the no therapy group). Nutritional data and relevant clinical data will be collected.
- Conditions
- Respiration Disorders, Respiratory Disease, Asthma in Children, Wheezing, Gastro-Intestinal Disorder, Healthy
- Being tested
- observational only - no interventions as part of study
- Keywords
- Gut-Lung Axis, Microbiome, Multi-omics, Children
- Medical subject headings
- Respiration Disorders, Respiratory Sounds, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational only - no interventions as part of studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Disease | Children with respiratory complications receiving general anaesthesia undergoing bronchoscopy Receives: Other: observational only - no interventions as part of study | |
| Gastrointestinal Disease | Children with G.I. complications receiving general anaesthesia undergoing endoscopy Receives: Other: observational only - no interventions as part of study | |
| Orthopaedic controls | Children with orthopaedic issue receiving general anaesthesia undergoing orthopaedic correction Receives: Other: observational only - no interventions as part of study | |
| Asthma Control | Children with Asthma/wheeze not indicated for biologics therapy Receives: Other: observational only - no interventions as part of study | |
| Asthma Treatment | Children with Asthma/wheeze indicated for biologics therapy Receives: Other: observational only - no interventions as part of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 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
Correlations between dietary factors (assessed via dietary questionnaires and/or food diary) on the gut-lung axis.
Measured: approximately up to 12 weeks before to 12-weeks after admission.
Multi-omics integration
Can a multi-omics view enhance our understanding of the gut-lung axis by integrating microbiome, immunological and nutritional/metabolic data.
Measured: At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start4 Feb 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Ross J Langley, MRCPCH, Principal investigator, NHS Greater Glasgow and Clyde Board HQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271213
- Sponsor's protocol ID
- 303841
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut-Lung Axis and Respiratory Illness in Children
- ClinicalTrials.gov ID
- NCT06271213
- Acronym / sponsor ID
- 303841
- Conditions
- Respiration Disorders, Respiratory Disease, Asthma in Children, Wheezing, Gastro-Intestinal Disorder, Healthy
- Keywords
- Gut-Lung Axis, Microbiome, Multi-omics, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The gut-lung axis is a postulated bi-directional connection between the gut and lung microbiomes where changes at one site can induce changes in another. Although pre-clinical evidence exists, the clinical evidence, particularly in paediatric patients is currently lacking. Changes in the gut microbiome in young children have been noted prior to asthma development although concomitant investigations into the gut and lungs have not yet been made in children with asthma. Furthermore, a causal relationship between IBD and respiratory disease has recently been noted. Associations have also been made between early-life environmental factors such as the protective effects of breastfeeding on respiratory health which hints at connections between dietary intake and respiratory health, possibly via the gut-lung axis. The investigators aim to investigate the gut-lung axis in children via a multi-omics approach.
Part A (cross-sectional): The investigators aim to investigate correlations between the gut and lung microbiome in 3 cohorts of children aged 0-16 attending the Royal Hospital for Children in Glasgow: Respiratory patients, GI patients and Orthopaedic patients. Although this is a hypothesis-generating study, the investigators would like to validate this bi-directional link between the gut and the lung microbiomes. The investigators hypothesise that children with respiratory disease should have a disturbed gut microbiome and children with GI disease should present with a disturbed respiratory microbiome (assessed ecologically and functionally via metabolic and molecular biology analyses). Children receiving orthopaedic procedures without active signs of respiratory or GI issues will serve as the benchmark of a healthy 'gut-lung axis'. The investigators will also aim to investigate potential mechanisms of communication between the gut and lungs in blood via immunological, metabolic, and molecular analyses. Dietary analysis, relevant clinical data and a health questionnaire will be completed by children. Additionally, a 3-day estimated weighed food diary will be completed by the participants and a validated Food Frequency Questionnaire (FFQ) in children aged 3 and above will be used to correlate dietary intake to biological date obtained relating to the gut-lung axis.
Part B (longitudinal): Investigating the Gut-Lung axis in asthma pre and post biologics therapy. The investigators aim to investigate connections between the airway and gut-microbiome, blood and responsiveness to patients receiving biologics therapy (as part of their standard of care). Two cohorts of children will be recruited: children with asthma/wheeze not indicated for biologics and children with asthma/wheeze indicated for biologics. The investigators aim to assess whether biologics modulate the gut-lung axis by sampling airways, stool and blood from children at two time points (before and after starting therapy, compared to the no therapy group). Nutritional data and relevant clinical data will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Respiratory Disease | – | Other: observational only - no interventions as part of studyChildren with respiratory complications receiving general anaesthesia undergoing bronchoscopy |
| Gastrointestinal Disease | – | Other: observational only - no interventions as part of studyChildren with G.I. complications receiving general anaesthesia undergoing endoscopy |
| Orthopaedic controls | – | Other: observational only - no interventions as part of studyChildren with orthopaedic issue receiving general anaesthesia undergoing orthopaedic correction |
| Asthma Control | – | Other: observational only - no interventions as part of studyChildren with Asthma/wheeze not indicated for biologics therapy |
| Asthma Treatment | – | Other: observational only - no interventions as part of studyChildren with Asthma/wheeze indicated for biologics therapy |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational only - no interventions as part of studyChildren 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. | Other | Asthma Control, Asthma Treatment, Gastrointestinal Disease, Orthopaedic controls, Respiratory Disease |
Primary outcome
Assess differences in gut and lung microbiota diversity between groups
Time frame: At admission on a single day
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)
Assess changes in gut and lung microbiota in children with asthma receiving biologics
Time frame: Measurement 1 at baseline. Measurement 2 anywhere from 8-52 weeks.
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.
Determine mediators of gut-lung axis in health and disease
Time frame: At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.
Are there statistically significant differences (p<0.05) in immunological/nutritional/metabolic/transcriptional factors in health and disease
2 secondary outcomes
Nutritional influence in gut-lung axis
Time frame: approximately up to 12 weeks before to 12-weeks after admission.
Multi-omics integration
Time frame: At admission on a single day. Between Timepoints A (baseline) and B (from 8-52 weeks) in asthma arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Related trials for Respiration Disorders
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ross J Langley, MRCPCH principal investigator
NHS Greater Glasgow and Clyde Board HQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration Disorders and Respiratory Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ross J Langley, MRCPCH (0141 451 6683, ross.langley@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess differences in gut and lung microbiota diversity between groups (time frame: At admission on a single day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.