Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Obstructive Pulmonary Disease
Design
Observational Model: Case-ControlTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Invite participants according to inclusion criteria and exclusion criteria and divide them into 4 groups, including healthy control (HC), high-risk COPD group (HG), early COPD group (EG), mild and moderate COPD group (MG). Research contents will be explained detailedly to the participants, and the h...

Invite participants according to inclusion criteria and exclusion criteria and divide them into 4 groups, including healthy control (HC), high-risk COPD group (HG), early COPD group (EG), mild and moderate COPD group (MG). Research contents will be explained detailedly to the participants, and the healthy participants and COPD patients who volunteer to participate in this study will sign the informed consent form (ICF) under the premise of adequate understanding. Collect clinical data of the participants and asses the severity of symptoms and the risk of acute exacerbation of COPD patients. Clinical data include general condition, history of past illness, history of present illness, personal history, family history and the examination results of blood routine, pulmonary function and compatible computed tomography. Breathlessness measurement adopt the modified British Medical Reseach Council (mMRC); symptoms measurement adopt COPD assessment test (CAT); quality of life measurement adopt St. George's Respiratory Questionnaire (SGRQ); risk of acute exacerbation measurement adopt dyspnea?degree of airflow obstruction?smoking status and the number of exacerbation (DOSE) scoring system. Collect fecal specimens from the participants on the morning of the same day. During the first three days of collection, they should keep their daily dietary habits and avoid sudden changes in dietary habits. Considerations: first remove the urine, excrement into a clean dry container, do not mix with urine and other sundries; the part of the feces that do not contact the air and container is taken from the specimen; women who are menstruating cannot be sampled. Each participant collect 3 fecal samples with a sterile spoon in a sterile enzyme-free cryopreservation tube, label the sample name and date, quickly placed in a -20? refrigerator, and transported to the hospital within 2 hours, where they were stored at -80?. Fecal microbiome are detected by 16S rRNA gene sequencing and metabolite short chain fatty acid (SCFA) are detected by Gaschromatography (GC). Serum of participants are collected at the clinical laboratory and detect indicators related to immune function by enzyme-linked immunosorbent assay (ELISA). Explore the characteristics of intestinal microbiome during the early progression of COPD, the correlation between the changes of intestinal microbiome and the severity and risk of acute exacerbation of COPD, the correlation between microbial metabolites SCFA and immune function of COPD.

Tracking Information

NCT #
NCT04876833
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
Study Chair: Yun Liu, MD Second Affiliated Hospital of Xi'an Jiaotong University