Changes in the respiratory and faecal microbial and biochemical environment after the initiation of a triple CFTR targeted treatment in patients with cystic fibrosis

Changes in the respiratory and faecal microbial and biochemical environment after the initiation of a triple CFTR targeted treatment in patients with cystic fibrosis - CF Triple Therapy Microbiome study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54939

Enrollment

Registered

2019-08-28

Start date

2019-10-30

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

12 Years to 64 Years

Inclusion criteria

Inclusion criteria: Start with Elexa-/Teza-/Ivacaftor therapy on basis of compassionate use

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Four visits are planned per patient as part of standard care. Material will obtained during all visits. Lung function, microbial cultures of sputum and blood sampling will be performed as part of routine care. An oral wash, nasal wash, and exhaled breath, and faeces and DBS with a finger prick collection will be obtained as additional procedure. Functional metagenomics and metabolomics analysis will be performed on sputum samples, oral and nasal wash, and faeces samples. The primary endpoint is the change in bacterial diversity after the start of Elexacaftor/Tezacaftor/Ivacaftor.	—

Measure

Time frame

Four visits are planned per patient as part of standard care. Material will obtained during all visits. Lung function, microbial cultures of sputum and blood sampling will be performed as part of routine care. An oral wash, nasal wash, and exhaled breath, and faeces and DBS with a finger prick collection will be obtained as additional procedure. Functional metagenomics and metabolomics analysis will be performed on sputum samples, oral and nasal wash, and faeces samples. The primary endpoint is the change in bacterial diversity after the start of Elexacaftor/Tezacaftor/Ivacaftor.

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Countries

Netherlands

Outcome results