Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasis Patients.

NCT04966793 | Recruiting

• 1 other identifier: 2020-066
• Study Type: observational
• Target: 1,850
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Microbiology

Outcome Measures

Primary Outcomes (2)

• Change from baseline SNP of PA population in sputum samples

  To assess the SNP changes of PA population in sputum samples compared with PAO1 wildtype

  once per 3 month for 3 years

• Species richness and antibiotic suscepibility change from baseline in sputum samples

  To assess the species richness and antibiotic suscepibility change from baseline in sputum samples

  once per 3 month for 3 years

Secondary Outcomes (5)

• pulmonary function

  once per year for 3 years

• chest CT

  once per year for 3 years

• BSI scores

  once per year for 3 years

• E-FACED scores

  once per year for 3 years

• SGRQ questionnaire

  once per year for 3 years

Study Arms (2)

Bronchiectasis patients group

Bronchiectasis patients group: Sputum specimens from bronchiectasis patients aged 18 to 79 years old .

Healthy control group

Healthy control group: Sputum specimens from healthy people.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bronchiectasis patients aged 18 to 79.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial People's Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Nanjing Jiangning Hospital: collaborator
• Tongji Hospital: collaborator
• Huadong Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Beijing Chest Hospital, Capital Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Shandong Public Health Clinical Center: collaborator
• The First Medical Center of Chinese PLA General Hospital: collaborator

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

sputum sample

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Feng Xu, Doctor

CONTACT

13666697918; xufeng99@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 19, 2021
• Study Start: February 20, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-06

Locations

CN (1)