Analysis of the Microbiome in the Healthy Smokers and COPD Patients

NCT04336423 | Unknown

• 1 other identifier: Microbiome cohort
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (COPD) patients. The aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and COPD patients.

Conditions

Pulmonary Disease, Chronic Obstructive; Microbiota

Keywords

Chronic obstructive pulmonary disease; Microbiome

Outcome Measures

Primary Outcomes (2)

• Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysis

  DNA is extracted from each sample from each patient by using a DNA Isolation Kit. The 16S universal primers are used for amplification of 16S ribosomal ribonucleic acid (rRNA) genes with polymerase chain reaction (PCR) system. After amplication, sequencing is performed using the GREENGENES database, after which a metagenomic analysis was performed by the MD Healthcare corporation using MDx-Pro software (Ver.1, Seoul, South Korea). Taxonomic assignment of these sequences is carried out with an operational taxonomic unit (OTU) cutoff of 3%.

  An average of 3 months

• Microbiome composition by metagenomic analysis

  The composition of microbiome is presented as bar graph.

  An average of 3 months

Secondary Outcomes (2)

• Biodiversity described by the Shannon diversity index and the Simpson index

  An average of 3 months

• Biodiversity described by Principal Component Analysis (PCA)

  An average of 3 months

Study Arms (2)

Healthy smoker

Healthy smokers with smoking history at least 10 pack-years and normal spirometry value

Diagnostic Test: Obtain samples from sputum and feces

COPD patient

Patients with smoking history at least 10 pack-years and persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7)

Diagnostic Test: Obtain samples from sputum and feces

Interventions

Obtain samples from sputum and feces DIAGNOSTIC_TEST

Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.

COPD patient; Healthy smoker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy smoker Healthy smokers with smoking history at least 10 pack-years and normal spirometry value COPD patient Patients with smoking history at least 10 pack-years and persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7)

You may qualify if:

• Patients with smoking history at least 10 pack-year
• Patients with persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7)

You may not qualify if:

• Patients with co-existing illness that would interfere with study results (e.g., malignancy, congestive heart failure, cerebrovascular disorders, chronic renal failure, diabetes with severe complications, or uncontrolled hypertension)
• Patients with respiratory disease other than obstructive lung disease (e.g., previous pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (4)

• Erb-Downward JR, Thompson DL, Han MK, Freeman CM, McCloskey L, Schmidt LA, Young VB, Toews GB, Curtis JL, Sundaram B, Martinez FJ, Huffnagle GB. Analysis of the lung microbiome in the "healthy" smoker and in COPD. PLoS One. 2011 Feb 22;6(2):e16384. doi: 10.1371/journal.pone.0016384.

  PMID: 21364979 BACKGROUND

• Kim HJ, Kim YS, Kim KH, Choi JP, Kim YK, Yun S, Sharma L, Dela Cruz CS, Lee JS, Oh YM, Lee SD, Lee SW. The microbiome of the lung and its extracellular vesicles in nonsmokers, healthy smokers and COPD patients. Exp Mol Med. 2017 Apr 14;49(4):e316. doi: 10.1038/emm.2017.7.

  PMID: 28408748 BACKGROUND

• Morris A, Beck JM, Schloss PD, Campbell TB, Crothers K, Curtis JL, Flores SC, Fontenot AP, Ghedin E, Huang L, Jablonski K, Kleerup E, Lynch SV, Sodergren E, Twigg H, Young VB, Bassis CM, Venkataraman A, Schmidt TM, Weinstock GM; Lung HIV Microbiome Project. Comparison of the respiratory microbiome in healthy nonsmokers and smokers. Am J Respir Crit Care Med. 2013 May 15;187(10):1067-75. doi: 10.1164/rccm.201210-1913OC.

  PMID: 23491408 BACKGROUND

• Cabrera-Rubio R, Garcia-Nunez M, Seto L, Anto JM, Moya A, Monso E, Mira A. Microbiome diversity in the bronchial tracts of patients with chronic obstructive pulmonary disease. J Clin Microbiol. 2012 Nov;50(11):3562-8. doi: 10.1128/JCM.00767-12. Epub 2012 Aug 22.

  PMID: 22915614 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

sputum, fecal samples every 6 months for 30 healthy smokers for 3 years sputum, fecal samples every 3 months for 30 COPD patients for 3 years

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Defecation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Sei Won Lee, M.D. Ph.D.

  University of Ulsan College of Medicine, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sei Won Lee, M.D. Ph.D.

CONTACT

82-2-3010-3990; iseiwon@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: April 6, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)