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

Cystic Fibrosis Clinical Trial

— NUTRIMUCO  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06072365
• Other study ID #: RC31/21/0364
• Secondary ID: 2021-A02018-33
• Status: Completed
• Start date: October 21, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 15, 2023
• Est. primary completion date: September 23, 2022
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	UHBordeaux	Bordeaux
France	UHLimoges	Limoges
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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