It is expected that the respiratory microbiome will be relatively stable over time in non-infectious patients.
Brief title
Health condition
COPD, bacteria, viruses
COPD, bacteriën, virussen
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the optimal sample type for respiratory microbiome analysis using the IS-pro technology.
Secondary outcome
1. Intra-patient analysis to define and compare the respiratory microbiome and its microbial diversity by BAL fluid, bronchial aspirate, induced sputum samples, throat and nose swabs;
2. Longitudinal analysis of respiratory microbiome in sputum, throat and nose swabs, to assess the respiratory microbiome and the microbial diversity of patients over time, between the same and different sample types.
Background summary
The human microbiome has gained interest in health and disease. For a long time, it was believed that the lungs of healthy individuals were sterile. More recently, it was shown that the lungs of both healthy individuals and diseased patients consisted of a rich respiratory microbiome, even in the absence of symptoms of an infection. Until now, different sampling methods have been used for respiratory microbiome analyses, including both invasive as well as non-invasive techniques. In addition, different technologies were applied, with the interspace-region-based profiling (IS-pro) method as a new technology tested on the intestinal microbiome. Until now, no lung samples have been tested by the IS-pro technology, although this technology has some advantages over next-generation sequencing. Research showed that IS-profiling is highly reproducible, fast and easy to perform and suitable for high-throughput profiling of the human intestinal microbiome. Therefore, the IS-pro technology is more readily adoptable to routine diagnostics compared to next-generation sequencing.
Study objective
It is expected that the respiratory microbiome will be relatively stable over time in non-infectious patients.
Study design
Baseline (visit 1)
Visit 2 (1/2 weeks after visit 1)
Visit 3 (half year after visit 1)
Intervention
Nose swab
Throat swab
Sputum
Bronchial aspirate
Mini-BAL
Dionne Braeken
Maastricht
The Netherlands
043-3874448
dionne.braeken@mumc.nl
Dionne Braeken
Maastricht
The Netherlands
043-3874448
dionne.braeken@mumc.nl
Inclusion criteria
In order to be eligible to participate in the study, a patient must meet all of the following criteria:
• Diagnosis of COPD stages I-IV, class A-D, as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD)23;
• Patients must be planned to undergo a bronchoscopy;
• Patients must be able to complete questionnaires;
• Patients must sign and date an informed consent prior to inclusion.
Exclusion criteria
A patient who meets any of the following criteria will be excluded from participation in this study:
• Chronic use of oral corticosteroids > 10 mg/day;
• Investigator’s uncertainty about the willingness or ability of the subject to comply with the protocol requirements, e.g. not smoking 6 hours before and fasting two hours before sputum induction;
• Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
• Patients unlikely to comply with the protocol, e.g. uncooperative attitude, and unlikelihood of completing the study (not able to attend all three visits).
Design
Recruitment
(Historical) registrations known in this register
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5220 |
| NTR-old | NTR5369 |
| CCMO | NL49157.068.14 |