Status:
COMPLETED
CFTR Modulators and Gastrointestinal Complications
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
The Leeds Teaching Hospitals NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Cystic Fibrosis
Gastrointestinal System Disease
Eligibility:
All Genders
Brief Summary
To elucidate the similarities and distinctions in non-pulmonary manifestations of cystic fibrosis (CF) including distal intestinal obstruction syndrome (DIOS) incidence and pancreatic enzyme replaceme...
Detailed Description
Cystic fibrosis (CF) is a autosomal recessive multi-system disorder caused by mutations to the cystic fibrosis transmembrane conductance regulator (CFTR) gene. As well as the documented respiratory co...
Eligibility Criteria
Inclusion
- All patients with CF of any genotype on the UK and US cystic fibrosis registries from the period 2007 - 2018.
Exclusion
- \- Patients whose CFTR modulator status is unknown or only have one year of CFTR data recorded on the registry will be excluded from the analysis of the effects of CFTR modulators. This is to account for the fact that DIOS data is annualised on the registries, therefore there is no certainty at what time of year DIOS was diagnosed in relation to commencing CFTR modulator therapy.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2024
Estimated Enrollment :
47023 Patients enrolled
Trial Details
Trial ID
NCT05253859
Start Date
October 1 2021
End Date
February 10 2024
Last Update
July 3 2024
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH