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Clinical Trials in France / NCT05937815
Recruiting Not applicable

Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor

NCT05937815 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Bordeaux
Phase
Not applicable
Started
2021-09-13
Last updated
2026-06-22

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

Sample collection

Sample collection: collection of sputum, stool and blood samples at baseline, 6 months and 1 year after baseline

Study summary

Cystic fibrosis is a systemic disease, which affects in particular the respiratory and digestive systems of patients, sites of chronic inflammation.

A new combination of elexacaftor/tezacaftor/ivacaftor has proven its efficacy for the treatment of patients aged 12 years and over with two F508del mutations or a so-called "minimal function" mutation associated with one F508del mutation. European marketing authorization was obtained in August 2020 and access in France should therefore arrive soon. Given that this treatment targets new mutations and that the efficacy seems greater than with LUM/IVA, it is important to assess its impact on the microbiota and the pulmonary and digestive inflammation of patients.

It is therefore a question of taking advantage of the experience of the Lum-Iva-Biota cohort, and the validated and operational sample circuit established in the various participating centers to set up a biological collection for the collection and storage of sputum and stools of patients during the first year of treatment with elexacaftor/tezacaftor/ivacaftor, in order to study the effect of treatment on the lung and digestive microbiota/mycobiota and inflammation.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * To have cystic fibrosis (sweat test \> 60 mmol/l); * Carrier of at least one DeltaF508 mutation; * Be followed in the current care by a participant in the CRCM study; * Start treatment with elexacaftor/tezacaftor/ivacaftor in routine care, according to the indications in the Marketing Authorization at the time of inclusion; * Be of the age specified in the marketing authorization in force; * Person affiliated or beneficiary of a social security scheme; * Consent obtained by the patient (for adult patients) or the holders of parental authority (for minor patients) before any examination required by the research and oral and/or written consent by the participant (depending on his or her age) . * Patient agreeing to take part in cohort follow-up studies of patients treated with elexacaftor/tezacaftor/ivacaftor, included in the French cystic fibrosis register (cf. Study by Pr BURGEL and/or MODUL CF). Exclusion Criteria: * Start of treatment with elexacaftor/tezacaftor/ivacaftor as part of a therapeutic trial. * Patient already on CFTR modulator (including lumacaftor/ivacaftor) * Vulnerable people (pregnant woman, person under guardianship/curators)

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
CHU de Bordeaux - CRCM pédiatrique Bordeaux France Recruiting
CHU de Grenoble Alpes CRCM pédiatrique Grenoble France Recruiting
CHRU de Lille CRCM Pédiatrique Lille France Recruiting
CHU de Limoges CRCM Limousin Limoges France Recruiting
Hospices Civils de Lyon Service de pédiatrie, allergologie et mucoviscidose Lyon France Recruiting
AP-HM CRCM pédiatrique Marseille France Recruiting
CHU de Montpellier Montpellier France Recruiting
CHU de Nancy Nancy France Recruiting
CHU de Nice Nice France Recruiting
AP-HP CRCM Robert debré Paris France Recruiting
AP-PH Hopital Cochin service de pédiatrie Paris France Recruiting
APHP Hopital Necker Paris France Recruiting
Fondation Ildys, Roscoff Centre Hélio Marin - Clinique "Mucoviscidose" Roscoff France Recruiting
CHU de Rouen Rouen France Recruiting
CHU de Toulouse Toulouse France Recruiting

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Other trials for the same condition

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting
Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis Recruiting
Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial Recruiting
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine Recruiting
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05937815 on ClinicalTrials.gov ↗ ← All trials in France