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SAW Lung Microbiome Study in Smokers and Never-smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562442
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : October 8, 2020
Sponsor:
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
Information provided by (Responsible Party):
Research Center Borstel

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Chronic Obstructive Pulmonary Disease (COPD) Healthy Microbial Colonization Behavioral: Smoking cessation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Leibniz Association Senate Board of Competition (SAW) Lung Microbiome Study
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Smokers

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

 Behavioral: Smoking cessation
Smoking cessation with or without professional / medical support
No Intervention: Never-Smokers
Healthy caucasian volunteers who never smoked are investigated once only (Visit 1)


Outcome Measures
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Primary Outcome Measures :
  1. Change in microbiome pattern in smokers after smoking cessation [ Time Frame: 6 Weeks ]
    Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture


Secondary Outcome Measures :
  1. Smoking cessation rates [ Time Frame: 6 weeks ]
    Percentage of sustained smoking cessation

  2. Smoking cessation rates [ Time Frame: 6 months ]
    Percentage of sustained smoking cessation

  3. Lung microbiome in never-smokers [ Time Frame: 0 days ]
    Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562442


Locations
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Germany
Research Center Borstel
Borstel, Schleswig-Holstein, Germany, 23845
Sponsors and Collaborators
Research Center Borstel
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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Research Center Borstel
ClinicalTrials.gov Identifier: NCT03562442    
Other Study ID Numbers: SAW Lungenmikrobiom-Studie
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
 Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes