Changes in the respiratory and faecal microbial and biochemical environment after the initiation of a triple CFTR targeted treatment in patients with cystic fibrosis
Completed
- Conditions
- Cystic Fibrosis10006436
- Registration Number
- NL-OMON54939
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Start with Elexa-/Teza-/Ivacaftor therapy on basis of compassionate use
Exclusion Criteria
none
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Four visits are planned per patient as part of standard care. Material will<br /><br>obtained during all visits. Lung function, microbial cultures of sputum and<br /><br>blood sampling will be performed as part of routine care. An oral wash, nasal<br /><br>wash, and exhaled breath, and faeces and DBS with a finger prick collection<br /><br>will be obtained as additional procedure. Functional metagenomics and<br /><br>metabolomics analysis will be performed on sputum samples, oral and nasal wash,<br /><br>and faeces samples. The primary endpoint is the change in bacterial diversity<br /><br>after the start of Elexacaftor/Tezacaftor/Ivacaftor.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>