Pulmonary Immune Cell-microbiome Interactions in the Healthy Lung
ConditionHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorHvidovre University Hospital
About this trial
The overall aim is to to provide a normal material for the composition and spatial heterogeneity of the following in the healthy lung: i) immune cell populations and their activation patterns, ii) the surrounding cytokine-chemokine milieu, including trans-compartmental fluxes of these mediators between the lung and bloodstream, and iii) the lung microbiome.
Main hypotheses:
* Absolute and relative immune cell counts in bronchoalveolar lavage fluid (BALF) are similar to those previously reported by other methods6,7. * No trans-compartmental flux of cytokines between the lungs and bloodstream is present, but cytokine concentrations (notably IL-6 and IL-8) vary with the immune-cell-microbiome composition. * Immune cell (mainly T cell) activation, differentiation, and gene expression patterns are expected to differ between blood and BALF in a manner that depends on the regional diversity of the pulmonary microbiome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women
Age 40 to 75
Disqualifiers
Immune deficiency
Lung disease
Active cancer or infection
Absolute contraindications for bronchoscopy
Trial population
Patients referred for elective surgery requiring intubation at Hvidovre Hospital
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Bronchoalveolar lavage
Procedure/SurgeryBronchoalveolar lavage in the middle lobe of the right lung and a mini-bronchoalveolar lavage in the upper and lower lobe of the right lung
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Women1 intervention
Group B: Men1 intervention
Trial outcomes
Primary outcomes
1
Lung microbiome
16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid
Time frame
Day 0 (subsequent to study inclusion)2
Lymphocyte populations
Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood
Time frame
Day 0 (subsequent to study inclusion)Secondary outcomes
1
Cell differential counts and cytomorphological analyses of BALF
Time frame
Day 0 (subsequent to study inclusion)2
Trans-compartmental fluxes
(calculated from plasma- and urea-adjusted BAL)
Time frame
Day 0 (subsequent to study inclusion)3
Auto-antibodies against tI-IFNs in blood
Measured in bronchoalveolar lavage fluid
Time frame
Day 0 (subsequent to study inclusion)4
White blood cells counts
Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
Time frame
Day 0 (subsequent to study inclusion)Sponsors and contacts
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Source ClinicalTrials.gov