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NCT06101459Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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?

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
19 Oct 2023
Start date
1 Dec 2023
Primary completion date
30 Jun 2028
Lead sponsor
Asan Medical Center
Diseases
COPD
NCT number
NCT06101459

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Dec 2023 to the primary completion date, 30 Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of acute exacerbation or antibiotics use within 3 months

Other

  • Withdrawal of informed consent
  • Difficulty to collect adequate stool, sputum and blood samples

Who the study is looking for

  • 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

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.