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

NCT06072365 | Completed

• 2 other identifiers: RC31/21/03642021-A02018-33
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cystic Fibrosis

Keywords

caloric intake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• caloric intake 3 months after the beginning of treatment

  3 months

Study Arms (1)

cystic fibrosis

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

Other: nutritional intake questionnaire

Interventions

nutritional intake questionnaire OTHER

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

cystic fibrosis

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Refusal to participate * Patients and/or holders of parental authority presenting difficulties in understanding and/or communication. * Inability to complete a reliable food collection. * Any pathological condition making interpretation of results difficult from the investigator's point of view. * Transplant patient * Pregnant or breastfeeding woman * Person under guardianship or curatorship.

You may qualify if:

• Patient with cystic fibrosis
• Patient with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization.
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

UHBordeaux

Bordeaux, 33404, France

Location

UHLimoges

Limoges, 87042, France

Location

UHToulouse

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 40378731 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Marion LAGARRIGUE

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: October 21, 2021
• Primary Completion: September 23, 2022
• Study Completion: January 15, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

FR (3)