A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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?
Primary outcome measures
- Shannon diversity index [Time frame: At enrollment]
- Simpson index [Time frame: At enrollment]
- Principal component analysis [Time frame: At enrollment]
- Microbiome composition by metagenomic analysis [Time frame: At enrollment]
- Peripheral blood mononuclear cells level [Time frame: At enrollment]
- Acetic acid level [Time frame: At enrollment]
- Propionic acid level [Time frame: At enrollment]
- Isobutyric acid level [Time frame: At enrollment]
- Butyric acid level [Time frame: At enrollment]
- Isovaleric acid level [Time frame: At enrollment]
Secondary outcome measures (4)
- Difference of microbiome according to Exacerbation [Time frame: within 1 year after enrollment]
- Difference of metabolome according to Exacerbation [Time frame: within 1 year after enrollment]
- Difference of microbiome according to death [Time frame: within 1 year after enrollment]
- Difference of metabolome according to death [Time frame: within 1 year after enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06101459 · 2023-1049