Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02018-33 | Other Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cystic fibrosis | patient with cystic fibrosis treated with With Elexacaftor/Tezacaftor/Ivacaftor, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional intake questionnaire | Other | patients completed a nutritional intake questionnaire before to start the treatment, 3mounths after and twelve months after |
|
| Measure | Description | Time Frame |
|---|---|---|
| caloric intake 12 months after the beginning of treatment | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| caloric intake 3 months after the beginning of treatment | 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 3 months. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marion LAGARRIGUE | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHBordeaux | Bordeaux | 33404 | France | |||
| UHLimoges |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40378731 | Derived | Enaud R, Languepin J, Lagarrigue M, Arrouy A, Macey J, Bui S, Dupuis M, Roditis L, Flumian C, Mas E, Mittaine M. Dietary intake remains unchanged while nutritional status improves in children and adults with cystic fibrosis on Elexacaftor/Tezacaftor/Ivacaftor. Clin Nutr. 2025 Jul;50:76-82. doi: 10.1016/j.clnu.2025.04.027. Epub 2025 Apr 30. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Limoges |
| 87042 |
| France |
| UHToulouse | Toulouse | 31059 | France |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |