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

Pilot study: Respiratory microbiome analysis by the IS-pro technology - The Maastricht Respiratory Microbiome Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44188
Enrollment
20
Registered
2015-04-08
Start date
2015-09-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

community of microorganisms microbiome

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
To determine the optimal sample type for respiratory microbiome analysis using the IS-pro technology.

Secondary

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)