Changes in the respiratory microbial and biochemical environment after the start of CFTR targeted treatment in patients with cystic fibrosis

Changes in the respiratory microbial and biochemical environment after the start of CFTR targeted treatment in patients with cystic fibrosis - Microbiome changes after CFTR targeted therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45428

Enrollment

Registered

2017-03-23

Start date

2017-11-13

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Cystic fibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a (predominant) class II mutation (almost exclusively homozygous Phe508del) for cystic fibrosis (N

Exclusion criteria

Exclusion criteria: For the bronchoscopy (part of the research protocol) the following patients will be excluded: * Pre-lung transplant trajectory * No informed consent for the procedure * Deemed inappropriate by the treating physician.

Design outcomes

Primary

Measure	Time frame
* Bacterial sequences in sputum, broncho-alveolar lavage fluid and oral and nasal wash. * Metabolic profiles in broncho-alveolar lavage fluid and oral wash by mass spectrometry. * Volatile metabolites in breath.	—

Secondary

Measure	Time frame
* Bacterial culture result from sputum and broncho-alveolar lavage fluid. * Lung function test results (FEV1/FVC, etc). * Routine plasma parameters of (chronic) inflammation (IgG, CRP, leukocyte count) and inflammatory profiles of sputum and broncho-alveolar lavage fluid measured by luminex. * Quality of life and fatigue assessments.	—

Countries

Netherlands

Outcome results