Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2020-02-20
Last updated
2025-11-20
Condition(s) studied
Bronchiectasis
Study summary
Qualified sputum samples from bronchiectasis patients were collected regularly every month for three consecutive years to analyze the microbiome changes of lower respiratory tract of bronchiectasis patients by metagenomic sequencing. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution，including virulence, quorum sensing and drug resistance under host pressure. The aim of the study is to clarify the rule of microflora colonization distribution and adaptive evolution in the lower respiratory tract of patients with bronchiectasis, to predict the acute attack and prognosis of patients with microbiome changes, and to find more new prevention and treatment methods by adjusting the microbiome of the lower respiratory tract.
Eligibility
Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Change from baseline SNP of PA population in sputum samples — once per 3 month for 3 years To assess the SNP changes of PA population in sputum samples compared with PAO1 wildtype
Species richness and antibiotic suscepibility change from baseline in sputum samples — once per 3 month for 3 years To assess the species richness and antibiotic suscepibility change from baseline in sputum samples
Trial sites (1)
Facility
City
Region
Status
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
Recruiting
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