Pilot study: Respiratory microbiome analysis by the IS-pro technology

Completed

Conditions: microbiome
10038716
community of microorganisms

Registration Number: NL-OMON44188

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 21

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the optimal sample type for respiratory microbiome analysis using<br /><br>the IS-pro technology. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Intra-patient analysis to define and compare the respiratory microbiome and<br /><br>its microbial diversity by BAL fluid, bronchial aspirate, induced sputum<br /><br>samples, throat and nose swabs;<br /><br>- Longitudinal analysis of respiratory microbiome in sputum, throat and nose<br /><br>swabs, to assess the respiratory microbiome and the microbial diversity of<br /><br>patients over time, between the same and different sample types.</p><br>