Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2023-11-09
Brief Title:
Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
The Interaction Between Viral Infections and the Development of the Airway Microbiome in Young Children With Cystic Fibrosis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
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:
Cystic fibrosis CF is the most common hereditary life-threatening condition in Belgium Because of a dysfunctional cystic fibrosis transmembrane conductance regulator CFTR channel chloride is unable to move to the cell surface and mucus becomes more viscous Consequently CF patients are not able to clear their lungs efficiently and trapped bacteria can lead to chronic infection and inflammation of the lungs and ultimately respiratory failure
CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF Additionally young children with CF suffer from viral infections as often as their healthy peers but the episodes are more severe and often prolonged Moreover frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age Although this link has been previously reported the exact mechanisms by which this occurs need to be elucidated
A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms general symptoms and a decline in lung function Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed Despite the current novel therapies in CF treatment of respiratory infections stay relevant and is a greater challenge with increasing survival
The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF
About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital Inclusion criteria are an age of less than 5 years and a diagnosis of CF There are no exclusion criteria Duration of the study is 1 year to cover for seasonality of clinical symptoms Study visits are scheduled at 3-month intervals corresponding with the regular follow up or unscheduled during an acute pulmonary exacerbation From all participants two oropharyngeal swabs for microbiome analysis and for immunologicalmucin analysis will be collected at set time points For the linking of the laboratory data to the clinical characteristics we will examine demographics environmental exposures and disease markers of CF Next to the collection of the oropharyngeal swabs a history physical examination and technical investigations will be performed at the study visits
CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF Additionally young children with CF suffer from viral infections as often as their healthy peers but the episodes are more severe and often prolonged Moreover frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age Although this link has been previously reported the exact mechanisms by which this occurs need to be elucidated
A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms general symptoms and a decline in lung function Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed Despite the current novel therapies in CF treatment of respiratory infections stay relevant and is a greater challenge with increasing survival
The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF
About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital Inclusion criteria are an age of less than 5 years and a diagnosis of CF There are no exclusion criteria Duration of the study is 1 year to cover for seasonality of clinical symptoms Study visits are scheduled at 3-month intervals corresponding with the regular follow up or unscheduled during an acute pulmonary exacerbation From all participants two oropharyngeal swabs for microbiome analysis and for immunologicalmucin analysis will be collected at set time points For the linking of the laboratory data to the clinical characteristics we will examine demographics environmental exposures and disease markers of CF Next to the collection of the oropharyngeal swabs a history physical examination and technical investigations will be performed at the study visits
Detailed Description:
None
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