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Study identifier: NCT05937815 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Cystic Fibrosis  ·  Sponsor: University Hospital, Bordeaux

PhaseNA
Planned participants253
Who can joinAll sexes, 6 Years to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Aurore Capelli, PhD  ·  0557820877  ·  aurore.capelli@chu-bordeaux.fr

Raphaël Enaud, MDPhD  ·  05 56 79 98 24  ·  raphael.enaud@chu-bordeaux.fr

Always discuss trial participation with your own doctor first.

Locations (15)

CHU de Bordeaux - CRCM pédiatriqueBordeaux, FranceRecruiting
CHU de Grenoble Alpes CRCM pédiatriqueGrenoble, FranceRecruiting
CHRU de Lille CRCM PédiatriqueLille, FranceRecruiting
CHU de Limoges CRCM LimousinLimoges, FranceRecruiting
Hospices Civils de Lyon Service de pédiatrie, allergologie et mucoviscidoseLyon, FranceRecruiting
AP-HM CRCM pédiatriqueMarseille, FranceRecruiting
CHU de MontpellierMontpellier, FranceRecruiting
CHU de NancyNancy, FranceRecruiting
CHU de NiceNice, FranceRecruiting
AP-HP CRCM Robert debréParis, FranceRecruiting
AP-PH Hopital Cochin service de pédiatrieParis, FranceRecruiting
APHP Hopital NeckerParis, FranceRecruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05937815