Antwerp University Hospital
Edegem, 2650, Belgium
Location status: Recruiting
Location contact
Kim Van Hoorenbeeck, Prof. dr.
CONTACT
Kim Van Hoorenbeeck, Prof. dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07255430
This project aims to assess the relationship between the microbiome and virome composition, the immune responses, and the respiratory health of children with protracted bacterial bronchitis (PBB). In addition, we aim to evaluate how the standard treatment with azithromycin interacts with the components of the microbiome, virome and immune biomarkers.
Interested in participating?
Request InfoUp to 5 year
All sexes
Observational
Edegem, 2650, Belgium
Location status: Recruiting
Kim Van Hoorenbeeck, Prof. dr.
CONTACT
Kim Van Hoorenbeeck, Prof. dr.
PRINCIPAL_INVESTIGATOR
Protracted Bacterial Bronchitis (PBB) is an often underestimated disease, characterized by a persistent cough for more than four weeks, without other significant underlying symptoms. While generally treatable, it can lead to complications such as recurrent infections and airway damage (bronchiectasis). The reasons why some children develop PBB or subsequent complications while others do not remain unclear. Recent research suggests that an impaired immune response and microbiota dysbiosis may play a key role. This study aims to analyze the microbial and viral composition of the airways in children with PBB, its relationship with inflammation, and the effects of azithromycin. Oropharyngeal swabs will be collected from up to 160 children <5 years old diagnosed with PBB at UZA in a longitudinal setup during one year. At each routine consultation (five in total) and during an exacerbation episode, three oropharyngeal swabs will be collected from each child. The three swabs will be used to: (1) determine the microbiome composition using next-generation sequencing, (2) identify the virome composition using multiplex qPCR or similar approaches, and (3) quantify immune biomarkers (RNA and protein-level) and culture microbial isolates. These findings will help to better understand the role of the airway microbiome in young children with PBB and identify microorganisms that may have a pathogenic or protective role. Ultimately, this knowledge may contribute to the development of new and effective diagnostics and treatments for PBB from an early age.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
Description: Analysis of microbiome communities in airway samples will be performed using amplicon or shotgun sequencing to determine relative microbial abundances (in percentages) as the unit of measure, coupled with the use of bioinformatic tools for community structure analysis.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
Description: Detection of respiratory viruses from airway samples using RT-qPCR. Unit of Measure: percentage of positive samples (in percentages).
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
Immunological profiling will be performed in airway samples by determining (1) cytokine concentrations based on protein-level analysis such as ELISA (pg/mL) and/or (2) differential gene expression based on RNA analysis (log fold-change or similar metric).
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
Description: Microbial profiles will be associated with demographic, epidemiological and clinical data collected through standardized questionnaires and clinical assessments to determine relevant correlates. Unit of Measure: Statistical association measure (e.g., correlation coefficients or similar).
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
PBB events will be associated with demographic, epidemiological and clinical data collected through standardized questionnaires and clinical assessments to determine relevant correlates. Unit of Measure: Effect estimates (odds/prevalence/hazard ratios or similar).
Contact information is provided by the study sponsor or research team.
Irina Spacova, Prof. dr. ir.
CONTACT
Kim Van Hoorenbeeck, Prof. dr.
CONTACT
University Hospital, Antwerp
Other
Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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