NCT06072365

Treatment With Elexacaftor/Tezacaftor/Ivacaftor, in Patients With Cystic Fibrosis and Caloric Intake

Evaluation of the Change in Caloric Intake Before and 12 Months After the Initiation of Treatment With Elexacaftor/Tezacaftor/Ivacaftor, in Patients With Cystic Fibrosis.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 2 Years – 100 Years
• Healthy volunteers: —

Summary

The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Detailed description

Cystic fibrosis is a genetic pathology linked to a dysfunction of the CFTR protein. Undernutrition is common in the natural course of cystic fibrosis, it is linked to exocrine pancreatic insufficiency but also to the increase in energy expenditure due to respiratory damage. At a time when these CFTR modulators are greatly modifying the prognosis and management of cystic fibrosis, it is important to describe how caloric and nutritional intake evolve under treatment with Elexacaftor/Tezacaftor/Ivacaftor in order to be able, in the long term, to adapt nutritional recommendations under treatment with CFTR modulators. The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	nutritional intake questionnaire	patients completed a nutritional intake questionnaire before to start the treatment, 3mounths after and twelve months after

Timeline

• Start date: 2021-10-21
• Primary completion: 2022-09-23
• Completion: 2023-01-15
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

3 sites across 1 country: France