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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-21

Study Completion Date

2023-01-15

Brief Summary

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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.

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Detailed Description

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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

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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cystic fibrosis

patient with cystic fibrosis treated with With Elexacaftor/Tezacaftor/Ivacaftor,

nutritional intake questionnaire

Intervention Type OTHER

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

Interventions

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nutritional intake questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.