Airway Microbiome of Patients With Protracted Bacterial Bronchitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Protracted Bacterial Bronchitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Protracted bacterial bronchitis diagnostic

Children under five years old who attend pediatric outpatient visits or well-child visits at University Hospital Antwerp (UZA) and are diagnosed with Protracted bacterial bronchitis.

No interventions assigned to this group

Eligibility Criteria

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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.

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No