Cystic FibrosisNUTRIMUCONCT06072365
Treatment With Elexacaftor/Tezacaftor/Ivacaftor, in Patients With Cystic Fibrosis and Caloric Intake
An observational study of Cystic Fibrosis, run by University Hospital, Toulouse at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- nutritional intake questionnaire
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Oct 2021to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 100 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
France3 sites
UHBordeaux
Bordeaux, 33404
UHLimoges
Limoges, 87042
UHToulouse
Toulouse, 31059
About this study
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.
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- nutritional intake questionnaire
- Keywords
- caloric intake
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional intake questionnaireOther
patients completed a nutritional intake questionnaire before to start the treatment, 3mounths after and twelve months after
| Study group | Role | What they receive |
|---|---|---|
| cystic fibrosis | patient with cystic fibrosis treated with With Elexacaftor/Tezacaftor/Ivacaftor, Receives: Other: nutritional intake questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start21 Oct 2021
- Primary completion23 Sep 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion LAGARRIGUE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072365
- Sponsor's protocol ID
- RC31/21/0364
- Other IDs
- 2021-A02018-33
- Acronym
- NUTRIMUCO
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40378731
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06072365
- Acronym / sponsor ID
- NUTRIMUCO / RC31/21/0364
- Conditions
- Cystic Fibrosis
- Keywords
- caloric intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis | – | Other: nutritional intake questionnairepatient with cystic fibrosis treated with With Elexacaftor/Tezacaftor/Ivacaftor, |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional intake questionnairepatients completed a nutritional intake questionnaire before to start the treatment, 3mounths after and twelve months after | Other | cystic fibrosis |
Primary outcome
caloric intake 12 months after the beginning of treatment
Time frame: 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.
1 secondary outcome
caloric intake 3 months after the beginning of treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 40378731Enaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion LAGARRIGUE principal investigator
University Hospital, Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Toulouse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caloric intake 12 months after the beginning of treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.