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

Sponsor
University Hospital, Bordeaux
Study ID
NCT05937815
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 10, 2023
Start date
Sep 13, 2021
Status verified
Jan 2026
Primary completion
Sep 13, 2026
Completion
Sep 13, 2026

Study Design

Enrollment
253 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: patients with cystic fibrosis
    patients with cystic fibrosis before and one year after the start of treatment with elexacaftor/tezacaftor/ivacaftor

Primary Outcome Measure

composition of the digestive bacterial microbiota [ Time Frame: 12 months after baseline (treatment initiation) ]

Central Contacts

Related Studies