Microbial colonization and evolution in the lower airways of people with bronchiectasis
Official title: Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasia Patients.
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT04966793 · Data updated 2026-11-12
This project will test whether monthly sputum microbiome profiling and Pseudomonas genome sequencing over three years can track how bacteria colonize and change in people with bronchiectasis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 1850 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 20, 2020 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT04966793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are clinically stable adults with CT-confirmed bronchiectasis, a history of two or more chest infections in the prior year, and chronic Pseudomonas aeruginosa colonization who can provide monthly sputum samples.
✕Probably not a fit
Patients actively exacerbating, current heavy smokers, those with cystic fibrosis, active tuberculosis, uncontrolled asthma, allergic bronchopulmonary aspergillosis, or who are pregnant or breastfeeding are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect qualified sputum samples from clinically stable bronchiectasis patients every month for three consecutive years and perform metagenomic sequencing to characterize lower respiratory tract microbiome changes. Pseudomonas aeruginosa isolates will be recovered and whole-genome sequenced to analyze adaptive evolution related to virulence, quorum sensing, and drug resistance under host pressure. The team aims to link microbiome dynamics and bacterial evolution to acute exacerbations and longer-term prognosis. Findings are intended to identify microbiome-based markers and potential targets for prevention or treatment strategies.
Why it matters
Potential benefit: If successful, the work could allow earlier prediction of exacerbations and identify microbiome-targeted approaches to reduce infections and improve outcomes.
How similar studies have gone: Previous longitudinal microbiome studies have linked bacterial community shifts to exacerbations, but tracking whole-genome adaptive evolution of Pseudomonas in bronchiectasis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bronchiectasis patients in clinically stable period; * Two or more chest infections in the previous year; * Chest CT confirmed bronchiectasis (bronchial to arterial ratio \>1). * Chronic colonization of pseudomonas aeruginosa and was clinically stable in 6 months prior to the study. Exclusion Criteria: * deterioration of illness (defined as at least 24 hours of three or more of the following symptoms: increased cough, increased sputum volume, purulent sputum, hemoptysis, increased dyspnea, increased wheezing, fever ((≥38°C) or discomfort, the attending physician agrees that antibiotic treatment is required); * current smokers, or former smokers who have stopped smoking less than 1 year ago, have a history of more than 15 packets of age, or CT showed as emphysema; * cystic fibrosis patients; * active allergic bronchopulmonary aspergillosis; * active tuberculosis patients; * patients with poor asthma control; * pregnant or breastfeeding women.
Where it's running
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2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Feng Xu, Doctor
- Email: xufeng99@zju.edu.cn
- Phone: 13666697918
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.