A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101459
• Other study ID #: 2023-1049
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.

The main questions it aims to answer are:

• Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?

• Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?

• Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker

• Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• COPD Patients, defined by FEV1/FVC <0.7, who

• agree with informed consent

• have no history of acute exacerbation within 3 months

• Healthy smoker without airflow limitation, defined by FEV1/FVC =0.7, who

• have smoking history with at least 30 pack-year

• agree with informed consent

• do not use medication for chronic respiratory disease

Exclusion Criteria:

• Withdrawal of informed consent

• History of acute exacerbation or antibiotics use within 3 months

• Difficulty to collect adequate stool, sputum and blood samples

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	HEM Pharma Inc., Seoul National University College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shannon diversity index	the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.	At enrollment
Primary	Simpson index	the investigators will compare alpha diversity and community similarity among groups by using the Simpson index.	At enrollment
Primary	Principal component analysis	the investigators will compare beta diversity and community similarity among groups by using the principal component analysis.	At enrollment
Primary	Microbiome composition by metagenomic analysis	The composition of microbiome will be presented as bar graph.	At enrollment
Primary	Peripheral blood mononuclear cells level	the investigators will compare the Peripheral blood mononuclear cells level among groups	At enrollment
Primary	Acetic acid level	the investigators will compare the acetic acid level among groups	At enrollment
Primary	Propionic acid level	the investigators will compare the Propionic acid level among groups	At enrollment
Primary	Isobutyric acid level	the investigators will compare the Isobutyric acid level among groups	At enrollment
Primary	Butyric acid level	the investigators will compare the butyric acid level among groups	At enrollment
Primary	Isovaleric acid level	the investigators will compare the Isovaleric acid level among groups	At enrollment
Primary	Valeric acid level	the investigators will compare the valeric acid level among groups	At enrollment
Primary	dimethylglycine level	the investigators will compare the dimethylglycine level among groups	At enrollment
Primary	secondary bile acid level	the investigators will compare the secondary bile acid level among groups	At enrollment
Secondary	Difference of microbiome according to Exacerbation	the investigators will investigate the baseline difference of microbiome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation	within 1 year after enrollment
Secondary	Difference of metabolome according to Exacerbation	the investigators will investigate the baseline difference of metabolome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation	within 1 year after enrollment
Secondary	Difference of microbiome according to death	the investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death	within 1 year after enrollment
Secondary	Difference of metabolome according to death	the investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death	within 1 year after enrollment