Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04336423
• Other study ID #: Microbiome cohort
• Status: Not yet recruiting
• Start date: April 6, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2020
• Source: Asan Medical Center
• Contact: Sei Won Lee, M.D. Ph.D.
• Phone: 82-2-3010-3990
• Email: iseiwon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

After the introduction of the gut-lung axis theory, extensive studies revealed the diversity of microbiomes among healthy smokers and COPD patients form the respiratory samples or lung tissues. In the previous study, distinct difference in composition of microbiome in lung tissue between healthy smokers and COPD patients was reported. 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 who are being followed up by Asan Medical Center. 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. This study would help establishing gut-lung axis model in humans.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Lung Diseases
• Microbiota
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• Obtain samples from sputum and feces
Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Cabrera-Rubio R, Garcia-Núñez M, Setó L, Antó JM, Moya A, Monsó 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Microbiome composition by metagenomic analysis	The composition of microbiome is presented as bar graph.	An average of 3 months
Secondary	Biodiversity described by the Shannon diversity index and the Simpson index	The Shannon index and the Simpson index is calculated by using metagenomic data.	An average of 3 months
Secondary	Biodiversity described by Principal Component Analysis (PCA)	PCA is performed for all 16S rRNA gene reads clustered at a 97% similarity.	An average of 3 months