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临床试验/NCT07255430
NCT07255430招募中不适用

Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年1月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Analysis of respiratory microbiome composition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with PBB diagnosis according to case definition
  • Consent form signed by parents or legal guardians

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Analysis of respiratory microbiome composition

时间窗: 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.

Prevalence of respiratory viruses

时间窗: 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).

次要结局

  • Immune biomarkers profiling in airway samples(Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations)
  • Correlates of respiratory microbiome(Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations)
  • Correlates of Protracted Bacterial Bronchitis(Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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