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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04966793
• Other study ID #: 2020-066
• Status: Recruiting
• Start date: February 20, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Feng Xu, Doctor
• Phone: 13666697918
• Email: xufeng99[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1850
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
China	2ndAffiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	pulmonary function	To assess the lung functon change	once per year for 3 years
Secondary	chest CT	To assess the severity of lung lesions	once per year for 3 years
Secondary	BSI scores	To assess the severity index of bronchiectasis.	once per year for 3 years
Secondary	E-FACED scores	To assess the severity index of bronchiectasis.	once per year for 3 years
Secondary	SGRQ questionnaire	To assess the impaired health and quality of life of patients with respiratory diseases	once per year for 3 years