Different sampling methods have been used for respiratory microbiome analyses, including both invasive as well as non-invasive techniques. We would like to investigate if the results of the bronchoscopy are comparable with results from the nose swab…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
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
- 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;
- 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
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. If this community of micro-organisms
differs between healthy individuals and patients with a lung disease has not
been sufficiently studied. Moreover, it's unknown which role these
micro-organisms play in patients with lung diseases.
Study objective
Different sampling methods have been used for respiratory microbiome analyses,
including both invasive as well as non-invasive techniques. We would like to
investigate if the results of the bronchoscopy are comparable with results from
the nose swab, throat swab or sputum sample, which are much easier sampling
methods. 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 design
Pilot study
Study burden and risks
All individuals are planned for bronchoscopy. The extra procedure of a mini-BAL
will not result in additional risks. The throat swab can give a gag reflex.
Risks associated with collecting induced sputum are bronchospastic reaction,
dyspnoea, vomiting, fear and cough. For this procedure, lung function is
necessary, which can result in cough, dizziness and hyperventilation. However,
these procedures are carried out under the supervision of experienced staff and
adjusted or stopped if necessary. Generally speaking, there is a low risk of
participating in this pilot study, as the potential risks are temporary.
Individuals are asked to come one and a half hour before bronchoscopy, for
sampling the throat and sputum. This is the same for the follow-up measures.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
* Diagnosis of COPD stages I-IV, class A-D, as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD);
* 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
* Chronic use of oral corticosteroids > 10 mg/day;
* Investigator*s uncertainty about the willingness or ability of the patient 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49157.068.14 |
| Other | Onderzoek wordt geregistreerd zodra goedkeuring is ontvangen (op www.trialregister.nl) |
| OMON | NL-OMON19937 |