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NCT Number: NCT04966793

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location status: Recruiting

About this study

Bronchiectasis is an abnormal, permanent dilatation of the bronchi, which presents as cough, expectoration and recurrent pulmonary infections. Epidemiological survey researchs have found that the number of bronchiectasis has increased rather than decreased in the last decades. Asia has the highest prevalence of bronchiectasis, with 1,200 cases in every 100,000 people over the age of 40 in China, and this rate can be seriously underestimated due to difficulties in identifying COPD. The mortality rate of bronchiectasis patients is more than twice that of the general population, placing an increasing burden on global health care systems. Chronic infection in bronchiectasis is common and had a big influence on prognosis. Pseudomonas aeruginosa is considered to be the most common colonization bacterium. At present, the mechanism of bronchiectasis and its relationship with lower respiratory tract infection have not been fully elucidated. Therefore, it is important to have an in-depth understanding of the colonization distribution and adaptive evolution of the microbiome in the lower respiratory tract, to predict the acute attack and prognosis with the application of microbiome changes, and to find more new and effective prevention and treatment methods by regulating the microbiome in the lower respiratory tract. Qualified sputum specimens from bronchiectasis patients were collected regularly every month for three consecutive years. Metagenomic sequencing was used to analyze the microbiome changes of lower respiratory tract in these patients. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution of its virulence, group sensitivity and drug resistance under host pressure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline SNP of PA population in sputum samples

    Time frame: once per 3 month for 3 years

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

  2. Species richness and antibiotic suscepibility change from baseline in sputum samples

    Time frame: once per 3 month for 3 years

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

Secondary outcomes

  1. pulmonary function

    Time frame: once per year for 3 years

    To assess the lung functon change

  2. chest CT

    Time frame: once per year for 3 years

    To assess the severity of lung lesions

  3. BSI scores

    Time frame: once per year for 3 years

    To assess the severity index of bronchiectasis.

  4. E-FACED scores

    Time frame: once per year for 3 years

    To assess the severity index of bronchiectasis.

  5. SGRQ questionnaire

    Time frame: once per year for 3 years

    To assess the impaired health and quality of life of patients with respiratory diseases

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Xu, Doctor

CONTACT

[email protected]

13666697918

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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