The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients
COPD
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 28, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedNovember 28, 2018
November 1, 2018
4 months
November 20, 2018
November 26, 2018
Conditions
Keywords
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 1 month
Microbiome composition by metagenomic analysis
The composition of microbiome is presented as bar graph.
An average of 1 month
Secondary Outcomes (2)
Biodiversity described by the Shannon diversity index and the Simpson index
An average of 1 month
Biodiversity described by Principal Component Analysis (PCA)
An average of 1 month
Study Arms (2)
Healthy Smoker
Healthy smoker with normal spirometry value
COPD
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)
Interventions
Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.
Eligibility Criteria
COPD group \- Same as above Healthy smokers * Participants with smoking history * Participants with normal spirometry results
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)
- Patients with recent (8 weeks prior to screening) exacerbation or other respiratory illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Songpa, 05505, South Korea
Related Publications (5)
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: 28408748BACKGROUNDMarsland 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.
PMID: 26595731BACKGROUNDPragman 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.
PMID: 23071781BACKGROUNDErb-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: 21364979BACKGROUNDLee SH, Kim J, Kim NH, Kim OH, Shon CH, Kim SJ, Jang Y, Yun S, Lim SE, Jung SY, Yoo HJ, Heo SH, Lee SW. Gut microbiota composition and metabolite profiling in smokers: a comparative study between emphysema and asymptomatic individuals with therapeutic implications. Thorax. 2023 Nov;78(11):1080-1089. doi: 10.1136/thorax-2021-217923. Epub 2023 Jul 26.
PMID: 37495367DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 28, 2018
Study Start
December 1, 2018
Primary Completion
March 31, 2019
Study Completion
September 30, 2019
Last Updated
November 28, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share