Clinical trial NCT06101459: A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
Official title: A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Microbiome
Metabolome
Smoking history
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University College of Medicine
name: HEM Pharma Inc.
First posted: 2023-10-26
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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?


Eligibility criteria: 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

Primary outcomes:
measure: Shannon diversity index
timeFrame: At enrollment
measure: Simpson index
timeFrame: At enrollment
measure: Principal component analysis
timeFrame: At enrollment
measure: Microbiome composition by metagenomic analysis
timeFrame: At enrollment
measure: Peripheral blood mononuclear cells level
timeFrame: At enrollment
measure: Acetic acid level
timeFrame: At enrollment
measure: Propionic acid level
timeFrame: At enrollment
measure: Isobutyric acid level
timeFrame: At enrollment
measure: Butyric acid level
timeFrame: At enrollment
measure: Isovaleric acid level
timeFrame: At enrollment
measure: Valeric acid level
timeFrame: At enrollment
measure: dimethylglycine level
timeFrame: At enrollment
measure: secondary bile acid level
timeFrame: At enrollment
Secondary outcomes:
measure: Difference of microbiome according to Exacerbation
timeFrame: within 1 year after enrollment
measure: Difference of metabolome according to Exacerbation
timeFrame: within 1 year after enrollment
measure: Difference of microbiome according to death
timeFrame: within 1 year after enrollment
measure: Difference of metabolome according to death
timeFrame: within 1 year after enrollment
Other outcomes:
Locations:
Study officials:
References: