The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

— COPD  

Official title:

The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03755505
• Other study ID #: 2018-0980
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2018
• 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

Extensive studies suggest composition of microbiome of respiratory samples or lung tissues in COPD patients is different from the composition of healthy smokers. Aim of this study is to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to describe difference of composition between COPD patients and healthy smokers.

Description:

After the introduction of the Gut-Lung axis theory, extensive studies revealed 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 is a cross sectional study to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to compare difference of composition between COPD patients and healthy smokers. This study would help establishing gut-lung axis model in humans.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A 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)

• Patients with recent (8 weeks prior to screening) exacerbation or other respiratory illness

Related Conditions & MeSH terms

• Chronic Disease
• Emphysema
• Emphysema or COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Microbiota
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul	Songpa

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — 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

Marsland BJ, Trompette A, Gollwitzer ES. The Gut-Lung Axis in Respiratory Disease. Ann Am Thorac Soc. 2015 Nov;12 Suppl 2:S150-6. doi: 10.1513/AnnalsATS.201503-133AW. Review. — View Citation

Pragman AA, Kim HB, Reilly CS, Wendt C, Isaacson RE. The lung microbiome in moderate and severe chronic obstructive pulmonary disease. PLoS One. 2012;7(10):e47305. doi: 10.1371/journal.pone.0047305. Epub 2012 Oct 11. — 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 1 month
Primary	Microbiome composition by metagenomic analysis	The composition of microbiome is presented as bar graph.	An average of 1 month
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 1 month
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 1 month