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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- caloric intake 12 months after the beginning of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cystic fibrosis
- •Patient with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization.
- •Patient who has not received treatment with CFTR modulators in the 6 months preceding inclusion.
- •No opposition expressed by the patient (if ≥ 18 years) or by at least one of the holders of parental authority and the child (if < 18 years).
- •Be affiliated to a social security scheme or be a beneficiary of such a scheme.
排除标准
- 未提供
结局指标
主要结局
caloric intake 12 months after the beginning of treatment
时间窗: 12 months
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.
次要结局
- caloric intake 3 months after the beginning of treatment(3 months)