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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Completed
• CT.gov ID: NCT06072365
• Collaborator: (none)
• Enrollment: 120
• Locations: 3
• Actual Duration (Months): 14.8
• Patients Per Site: 40
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: nutritional intake questionnaire

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Oct 21, 2021
• Actual Primary Completion Date: Sep 23, 2022
• Actual Study Completion Date: Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
cystic fibrosis patient with cystic fibrosis treated with With Elexacaftor/Tezacaftor/Ivacaftor,	Other: nutritional intake questionnaire; patients completed a nutritional intake questionnaire before to start the treatment, 3mounths after and twelve months after

Outcome Measures

Primary Outcome Measures

1. caloric intake 12 months after the beginning of treatment [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.

Secondary Outcome Measures

1. caloric intake 3 months after the beginning of treatment [3 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 3 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 100 Years
• Sexes Eligible for Study: All

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHBordeaux	Bordeaux		France	33404
2	UHLimoges	Limoges		France	87042
3	UHToulouse	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: Marion LAGARRIGUE, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT06072365
• Other Study ID Numbers: RC31/21/0364; 2021-A02018-33
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Toulouse: caloric intake
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Oct 10, 2023