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NCT Number: NCT06101459

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

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?

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Shannon diversity index

    Time frame: At enrollment

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

  2. Simpson index

    Time frame: At enrollment

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

  3. Principal component analysis

    Time frame: At enrollment

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

  4. Microbiome composition by metagenomic analysis

    Time frame: At enrollment

    The composition of microbiome will be presented as bar graph.

  5. Peripheral blood mononuclear cells level

    Time frame: At enrollment

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

  6. Acetic acid level

    Time frame: At enrollment

    the investigators will compare the acetic acid level among groups

  7. Propionic acid level

    Time frame: At enrollment

    the investigators will compare the Propionic acid level among groups

  8. Isobutyric acid level

    Time frame: At enrollment

    the investigators will compare the Isobutyric acid level among groups

  9. Butyric acid level

    Time frame: At enrollment

    the investigators will compare the butyric acid level among groups

  10. Isovaleric acid level

    Time frame: At enrollment

    the investigators will compare the Isovaleric acid level among groups

  11. Valeric acid level

    Time frame: At enrollment

    the investigators will compare the valeric acid level among groups

  12. dimethylglycine level

    Time frame: At enrollment

    the investigators will compare the dimethylglycine level among groups

  13. secondary bile acid level

    Time frame: At enrollment

    the investigators will compare the secondary bile acid level among groups

Secondary outcomes

  1. Difference of microbiome according to Exacerbation

    Time frame: within 1 year after enrollment

    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

  2. Difference of metabolome according to Exacerbation

    Time frame: within 1 year after enrollment

    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

  3. Difference of microbiome according to death

    Time frame: within 1 year after enrollment

    the investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death

  4. Difference of metabolome according to death

    Time frame: within 1 year after enrollment

    the investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • HEM Pharma Inc.
  • Seoul National University College of Medicine

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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