Airway Microbiome of Patients With Protracted Bacterial Bronchitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Protracted Bacterial Bronchitis. Basic parameters: up to 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis
Overview
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.
Detailed description
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.
Primary outcome measures
- Analysis of respiratory microbiome composition [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
- Prevalence of respiratory viruses [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
Secondary outcome measures (3)
- Immune biomarkers profiling in airway samples [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
- Correlates of respiratory microbiome [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
- Correlates of Protracted Bacterial Bronchitis [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
Eligibility criteria
Inclusion criteria
- Children with PBB diagnosis according to case definition
- Consent form signed by parents or legal guardians
Exclusion criteria
- Comorbidities (HIV, asthma, chronic obstructive pulmonary disease, diabetes)
- Have had serious illnesses (meningitis, pneumonia, bacteremia, empyema, etc) in the previous three months, identified only at the time of enrollment.
- Have chronic respiratory conditions at the time of enrollment (non-PBB bronchiectasis not caused by PBB, CF, allergy, etc.).
- Having received mechanical ventilation.
- Having been hospitalized or used antibiotics in the previous three months at the time of enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Antwerp University Hospital — Edegem
Identifiers
NCT: NCT07255430 · BUN B3002025000069