Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor (KAF-BIOTA)
Cystic Fibrosis
About this trial
This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring elexacaftor/tezacaftor/ivacaftor, lung and digestive microbiota and inflammation
Eligibility Criteria
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)
Sites / Locations
- CHU de Bordeaux - CRCM pédiatriqueRecruiting
- CHU de Grenoble Alpes CRCM pédiatriqueRecruiting
- CHRU de Lille CRCM PédiatriqueRecruiting
- CHU de Limoges CRCM LimousinRecruiting
- Hospices Civils de Lyon Service de pédiatrie, allergologie et mucoviscidoseRecruiting
- AP-HM CRCM pédiatriqueRecruiting
- CHU de MontpellierRecruiting
- CHU de NancyRecruiting
- CHU de NiceRecruiting
- AP-HP CRCM Robert debréRecruiting
- AP-PH Hopital Cochin service de pédiatrieRecruiting
- APHP Hopital NeckerRecruiting
- Fondation Ildys, Roscoff Centre Hélio Marin - Clinique "Mucoviscidose"Recruiting
- CHU de RouenRecruiting
- CHU de ToulouseRecruiting
Arms of the Study
Arm 1
Experimental
patients with cystic fibrosis
patients with cystic fibrosis before and one year after the start of treatment with elexacaftor/tezacaftor/ivacaftor