Exploring the effects of a new cystic fibrosis treatment on lung and gut health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of the combination therapy elexacaftor/tezacaftor/ivacaftor on the microbiota and inflammation in cystic fibrosis patients. It focuses on individuals aged 12 and older who have specific genetic mutations associated with cystic fibrosis. By collecting and analyzing sputum and stool samples, the study aims to understand the relationship between lung and intestinal health in these patients. The research builds on previous findings from the Lum-Iva-Biota cohort, which highlighted the distinct microbiota in cystic fibrosis patients compared to healthy individuals.

Why it matters

Who can join: the full rules

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)

Where it's running

• 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

Study contacts

• Principal investigator: Raphaël Enaud, MDPhD — University Hospital, Bordeaux
• Study coordinator: Aurore Capelli, PhD
• Email: aurore.capelli@chu-bordeaux.fr
• Phone: 0557820877

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.