Microbial colonization and evolution in the lower airways of people with bronchiectasis
Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasia Patients.
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 |
|---|---|
| Enrollment | 1850 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04966793 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous longitudinal microbiome studies have linked bacterial community shifts to exacerbations, but tracking whole-genome adaptive evolution of Pseudomonas in bronchiectasis is relatively novel.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.