Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876833
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2021-04-25
Brief Title:
Characteristics of Intestinal Microbiome in the Progression of Early COPD
Sponsor:
Second Affiliated Hospital of Xian Jiaotong University
Organization:
Second Affiliated Hospital of Xian Jiaotong University
Study Overview
Official Title:
Characteristics of Intestinal Microbiome in the Progression of Early Chronic Obstructive Pulmonary Disease
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is aiming at 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 Then reveal the influence of intestinal microecology on the development of COPD and the possible mechanism of intestinal microecology in the pathogenesis of COPD
Detailed Description:
1 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
2 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 Georges Respiratory Questionnaire SGRQ risk of acute exacerbation measurement adopt dyspneadegree of airflow obstructionsmoking status and the number of exacerbation DOSE scoring system
3 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
4 Serum of participants are collected at the clinical laboratory and detect indicators related to immune function by enzyme-linked immunosorbent assay ELISA
5 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
2 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 Georges Respiratory Questionnaire SGRQ risk of acute exacerbation measurement adopt dyspneadegree of airflow obstructionsmoking status and the number of exacerbation DOSE scoring system
3 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
4 Serum of participants are collected at the clinical laboratory and detect indicators related to immune function by enzyme-linked immunosorbent assay ELISA
5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None