Condition: Cystic Fibrosis · Sponsor: University Hospital, Bordeaux
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.
Aurore Capelli, PhD · 0557820877 · aurore.capelli@chu-bordeaux.fr
Raphaël Enaud, MDPhD · 05 56 79 98 24 · raphael.enaud@chu-bordeaux.fr
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| 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 |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05937815