RecruitingNot ApplicableNCT05937815

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

Monitoring of the Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor: Study of the Pulmonary and Gut Microbiota and Inflammation


Sponsor

University Hospital, Bordeaux

Enrollment

253 participants

Start Date

Sep 13, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Sample collection for people with cystic fibrosis. The study is currently recruiting participants at 15 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESample collection

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


Locations(15)

CHU de Bordeaux - CRCM pédiatrique

Bordeaux, France

CHU de Grenoble Alpes CRCM pédiatrique

Grenoble, France

CHRU de Lille CRCM Pédiatrique

Lille, France

CHU de Limoges CRCM Limousin

Limoges, France

Hospices Civils de Lyon Service de pédiatrie, allergologie et mucoviscidose

Lyon, France

AP-HM CRCM pédiatrique

Marseille, France

CHU de Montpellier

Montpellier, France

CHU de Nancy

Nancy, France

CHU de Nice

Nice, France

AP-HP CRCM Robert debré

Paris, France

AP-PH Hopital Cochin service de pédiatrie

Paris, France

APHP Hopital Necker

Paris, France

Fondation Ildys, Roscoff Centre Hélio Marin - Clinique "Mucoviscidose"

Roscoff, France

CHU de Rouen

Rouen, France

CHU de Toulouse

Toulouse, France

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NCT05937815


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