Clinical trial Recruiting at 1 site Observational Ages 18 to 79

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 typeObservational
Ages18 Years to 79 Years
SexAll
Enrollment1850 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedFebruary 20, 2020
Main results expectedJanuary 31, 2027
Study endsJanuary 31, 2027
Registry record updatedNovember 20, 2025
Trial IDNCT04966793 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

  • 2ndAffiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.