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

NCT06101459 | Not Yet Recruiting

• 1 other identifier: 2023-1049
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Microbiome; Metabolome; Smoking history

Outcome Measures

Primary Outcomes (13)

• Shannon diversity index

  the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.

  At enrollment

• Simpson index

  the investigators will compare alpha diversity and community similarity among groups by using the Simpson index.

  At enrollment

• Principal component analysis

  the investigators will compare beta diversity and community similarity among groups by using the principal component analysis.

  At enrollment

• Microbiome composition by metagenomic analysis

  The composition of microbiome will be presented as bar graph.

  At enrollment

• Peripheral blood mononuclear cells level

  the investigators will compare the Peripheral blood mononuclear cells level among groups

  At enrollment

• Acetic acid level

  the investigators will compare the acetic acid level among groups

  At enrollment

• Propionic acid level

  the investigators will compare the Propionic acid level among groups

  At enrollment

• Isobutyric acid level

  the investigators will compare the Isobutyric acid level among groups

  At enrollment

• Butyric acid level

  the investigators will compare the butyric acid level among groups

  At enrollment

• Isovaleric acid level

  the investigators will compare the Isovaleric acid level among groups

  At enrollment

• Valeric acid level

  the investigators will compare the valeric acid level among groups

  At enrollment

• dimethylglycine level

  the investigators will compare the dimethylglycine level among groups

  At enrollment

• secondary bile acid level

  the investigators will compare the secondary bile acid level among groups

  At enrollment

Secondary Outcomes (4)

• Difference of microbiome according to Exacerbation

  within 1 year after enrollment

• Difference of metabolome according to Exacerbation

  within 1 year after enrollment

• Difference of microbiome according to death

  within 1 year after enrollment

• Difference of metabolome according to death

  within 1 year after enrollment

Study Arms (3)

COPD patient with significant smoking history

Patients with following conditions 1. smoking history more than 30 pack\*year 2. FEV1/FVC ratio \<0.7 3. No acute exacerbation history within 3 months

COPD patient without significant smoking history

Patients with following conditions 1. smoking history less than 0.5 pack\*year 2. FEV1/FVC ratio \<0.7 3. No acute exacerbation history within 3 months

Healthy smoker

Patients with following conditions 1. smoking history more than 30 pack\*year 2. FEV1/FVC ratio ≥0.7 3. No current use of medication for any chronic respiratory disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. COPD patients with significant smoking history * FEV1/FVC \<0.7 in spirometry * Smoking history at least 30 pack-year 2. COPD patients without significant smoking history * FEV1/FVC \<0.7 in spirometry * No smoking history or smoking history at less than 0.5 pack-year 3. Healthy smoker * FEV1/FVC ≥0.7 in spirometry * Smoking history at least 30 pack-year

You may qualify if:

• 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

You may not qualify if:

• Withdrawal of informed consent
• History of acute exacerbation or antibiotics use within 3 months
• Difficulty to collect adequate stool, sputum and blood samples

Sponsors & Collaborators

• Asan Medical Center: lead
• Seoul National University College of Medicine: collaborator
• HEM Pharma Inc.: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal sample: the investigators will collect fecal sample (≥ 10g) and divided them into stool sample collection kit and OMNIgene GUT OMR-200 Kit (DNA Genotek, Canada). Sputum sample: the investigators will collect induced sputum sample from each subject. Induction with hypertonic saline (3%) will be performed. Blood sample: the investigators will retrieve 5cc blood sample from each patient. Blood samples will be centrifuged and stored as plasma and peripheral blood mononuclear cells, respectively. All samples will be freeze-dried for 24 hours using a benchtop manifold freeze drier and stored at -80°C until analysis.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 26, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 26, 2023

Record last verified: 2023-10