Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-07 @ 2:58 AM
Study NCT ID:
NCT06101459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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).\n\nSputum sample: the investigators will collect induced sputum sample from each subject. Induction with hypertonic saline (3%) will be performed.\n\nBlood 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.\n\nAll samples will be freeze-dried for 24 hours using a benchtop manifold freeze drier and stored at -80°C until analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shannon diversity index', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.'}, {'measure': 'Simpson index', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare alpha diversity and community similarity among groups by using the Simpson index.'}, {'measure': 'Principal component analysis', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare beta diversity and community similarity among groups by using the principal component analysis.'}, {'measure': 'Microbiome composition by metagenomic analysis', 'timeFrame': 'At enrollment', 'description': 'The composition of microbiome will be presented as bar graph.'}, {'measure': 'Peripheral blood mononuclear cells level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the Peripheral blood mononuclear cells level among groups'}, {'measure': 'Acetic acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the acetic acid level among groups'}, {'measure': 'Propionic acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the Propionic acid level among groups'}, {'measure': 'Isobutyric acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the Isobutyric acid level among groups'}, {'measure': 'Butyric acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the butyric acid level among groups'}, {'measure': 'Isovaleric acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the Isovaleric acid level among groups'}, {'measure': 'Valeric acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the valeric acid level among groups'}, {'measure': 'dimethylglycine level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the dimethylglycine level among groups'}, {'measure': 'secondary bile acid level', 'timeFrame': 'At enrollment', 'description': 'the investigators will compare the secondary bile acid level among groups'}], 'secondaryOutcomes': [{'measure': 'Difference of microbiome according to Exacerbation', 'timeFrame': 'within 1 year after enrollment', 'description': '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'}, {'measure': 'Difference of metabolome according to Exacerbation', 'timeFrame': 'within 1 year after enrollment', 'description': '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'}, {'measure': 'Difference of microbiome according to death', 'timeFrame': 'within 1 year after enrollment', 'description': 'the investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death'}, {'measure': 'Difference of metabolome according to death', 'timeFrame': 'within 1 year after enrollment', 'description': 'the investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Metabolome', 'Smoking history'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?\n* 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?\n* 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\n* Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. COPD patients with significant smoking history\n\n * FEV1/FVC \\<0.7 in spirometry\n * Smoking history at least 30 pack-year\n2. COPD patients without significant smoking history\n\n * FEV1/FVC \\<0.7 in spirometry\n * No smoking history or smoking history at less than 0.5 pack-year\n3. Healthy smoker\n\n * FEV1/FVC ≥0.7 in spirometry\n * Smoking history at least 30 pack-year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD Patients, defined by FEV1/FVC \\<0.7, who\n\n * agree with informed consent\n * have no history of acute exacerbation within 3 months\n* Healthy smoker without airflow limitation, defined by FEV1/FVC ≥0.7, who\n\n * have smoking history with at least 30 pack-year\n * agree with informed consent\n * do not use medication for chronic respiratory disease\n\nExclusion Criteria:\n\n* Withdrawal of informed consent\n* History of acute exacerbation or antibiotics use within 3 months\n* Difficulty to collect adequate stool, sputum and blood samples'}, 'identificationModule': {'nctId': 'NCT06101459', 'briefTitle': 'A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients', 'orgStudyIdInfo': {'id': '2023-1049'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patient with significant smoking history', 'description': 'Patients with following conditions\n\n1. smoking history more than 30 pack\\*year\n2. FEV1/FVC ratio \\<0.7\n3. No acute exacerbation history within 3 months'}, {'label': 'COPD patient without significant smoking history', 'description': 'Patients with following conditions\n\n1. smoking history less than 0.5 pack\\*year\n2. FEV1/FVC ratio \\<0.7\n3. No acute exacerbation history within 3 months'}, {'label': 'Healthy smoker', 'description': 'Patients with following conditions\n\n1. smoking history more than 30 pack\\*year\n2. FEV1/FVC ratio ≥0.7\n3. No current use of medication for any chronic respiratory disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University College of Medicine', 'class': 'UNKNOWN'}, {'name': 'HEM Pharma Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sei Won Lee', 'investigatorAffiliation': 'Asan Medical Center'}}}}