Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271213
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-30
Brief Title:
The Gut-Lung Axis and Respiratory Illness in Children
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
The Gut-Lung Axis and Respiratory Illness in Children
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor food frequency questionnaire to assess relationships between diet and the gut-lung axis
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 andor 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 asthmawheeze not indicated for biologics and children with asthmawheeze 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
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 asthmawheeze not indicated for biologics and children with asthmawheeze 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None