SAW Lung Microbiome Study in Smokers and Never-smokers
Primary Purpose
Smoking Cessation, Chronic Obstructive Pulmonary Disease (COPD), Healthy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Smoking cessation
Sponsored by
About this trial
This is an interventional basic science trial for Smoking Cessation
Eligibility Criteria
Inclusion Criteria:
- Cigarette consumption of at least five cigarettes per day
- Caucasian ethnicity
Exclusion Criteria:
- Continous passive smoking exposure
- Systemic steroid therapy during the previous month
- Chronic lung disease (exception COPD stage Global Initiative on Lung Disease (GOLD) 0/I/II)
- Diabetes mellitus
- Pregnancy or breast feeding
- active tuberculosis (currently or previously)
- respiratory infection in the previous month
- antibiotic therapy in the previous two months
- immunosuppression
- malignancy
- interstitial lung disease
- rheumatic disease with lung manifestation
- member of a collaborative group of the project
Sites / Locations
- Research Center Borstel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Smokers
Never-Smokers
Arm Description
Healthy caucasian smokers who are willing to quit smoking are investigated before cessation (Visit 1) and 6 weeks after cessation (Visit 2). Intervention: Smoking cessation
Healthy caucasian volunteers who never smoked are investigated once only (Visit 1)
Outcomes
Primary Outcome Measures
Change in microbiome pattern in smokers after smoking cessation
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
Secondary Outcome Measures
Smoking cessation rates
Percentage of sustained smoking cessation
Smoking cessation rates
Percentage of sustained smoking cessation
Lung microbiome in never-smokers
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
Full Information
NCT ID
NCT03562442
First Posted
May 26, 2018
Last Updated
October 6, 2020
Sponsor
Research Center Borstel
Collaborators
Leibniz Institute DSMZ - German Collection of Microorganisms and Cell Cultures, Leibniz Institute of Photonic Technology (IPHT), Jena, Germany, Technical University of Munich, Helmholtz Center Munich, Munich Germany
1. Study Identification
Unique Protocol Identification Number
NCT03562442
Brief Title
SAW Lung Microbiome Study in Smokers and Never-smokers
Official Title
Leibniz Association Senate Board of Competition (SAW) Lung Microbiome Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Center Borstel
Collaborators
Leibniz Institute DSMZ - German Collection of Microorganisms and Cell Cultures, Leibniz Institute of Photonic Technology (IPHT), Jena, Germany, Technical University of Munich, Helmholtz Center Munich, Munich Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
Detailed Description
The trial aims to analyze changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in healthy (and willing to quit) smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
Demographic and clinical data of the study subjects are obtained, aiming for homogeneous groups. All personal data are encrypted according to the standard operating procedures of the study site. Pharyngeal and deep nasal swabs are taken.
To avoid contamination of the lower airways from the oropharynx through the bronchoscope, standardized procedures are established according to the German guidelines for bronchoscopy. Before bronchoscopy, the endoscope is flushed with sterile saline which is analyzed for 16S ribosomal RNA (rRNA) to control for residual contaminating bacterial desoxyribonucleic acid (DNA). A 300ml bronchoalveolar lavage with warm normal saline solution is taken from the middle lobe. Three covered and "microbiologically protected" bronchial brushings are obtained from the right upper lobe. This sterile brush is sealed in wax and pushed through the wax just before taking the brushing. All samples are immediately frozen and stored at -80°C until further analyses. For cultivations, samples are kept at 4°C and rapidly processed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Chronic Obstructive Pulmonary Disease (COPD), Healthy, Microbial Colonization
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups are recruited in parallel (A) Smokers who quit smoking (Visit 1 before cessation, Visit 2 six weeks after cessation) (B) Never-smokers (Visit 1 only)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smokers
Arm Type
Experimental
Arm Description
Healthy caucasian smokers who are willing to quit smoking are investigated before cessation (Visit 1) and 6 weeks after cessation (Visit 2).
Intervention: Smoking cessation
Arm Title
Never-Smokers
Arm Type
No Intervention
Arm Description
Healthy caucasian volunteers who never smoked are investigated once only (Visit 1)
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation
Intervention Description
Smoking cessation with or without professional / medical support
Primary Outcome Measure Information:
Title
Change in microbiome pattern in smokers after smoking cessation
Description
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Smoking cessation rates
Description
Percentage of sustained smoking cessation
Time Frame
6 weeks
Title
Smoking cessation rates
Description
Percentage of sustained smoking cessation
Time Frame
6 months
Title
Lung microbiome in never-smokers
Description
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
Time Frame
0 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cigarette consumption of at least five cigarettes per day
Caucasian ethnicity
Exclusion Criteria:
Continous passive smoking exposure
Systemic steroid therapy during the previous month
Chronic lung disease (exception COPD stage Global Initiative on Lung Disease (GOLD) 0/I/II)
Diabetes mellitus
Pregnancy or breast feeding
active tuberculosis (currently or previously)
respiratory infection in the previous month
antibiotic therapy in the previous two months
immunosuppression
malignancy
interstitial lung disease
rheumatic disease with lung manifestation
member of a collaborative group of the project
Facility Information:
Facility Name
Research Center Borstel
City
Borstel
State/Province
Schleswig-Holstein
ZIP/Postal Code
23845
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34389656
Citation
Pfeiffer S, Herzmann C, Gaede KI, Kovacevic D, Krauss-Etschmann S, Schloter M. Different responses of the oral, nasal and lung microbiomes to cigarette smoke. Thorax. 2022 Feb;77(2):191-195. doi: 10.1136/thoraxjnl-2020-216153. Epub 2021 Aug 13.
Results Reference
derived
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SAW Lung Microbiome Study in Smokers and Never-smokers
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