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CF Drug's hidden impact on gut and lung bugs revealed

NCT ID NCT05937815

Knowledge-focused Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 253 cystic fibrosis patients starting a new drug combination (elexacaftor/tezacaftor/ivacaftor). Researchers collect sputum, stool, and blood samples at the start, 6 months, and 1 year to see how the drug changes bacteria and inflammation in the lungs and gut. The goal is to understand the drug's full effects beyond just breathing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elexacaftor/Tezacaftor/Ivacaftor
What this could lead to
If successful, this could reveal how the drug improves gut and lung health in cystic fibrosis, guiding better future treatments.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove the drug works or is safe, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 253 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cystic fibrosis Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM CRCM pédiatrique

    RECRUITING

    Marseille, France

  • AP-HP CRCM Robert debré

    RECRUITING

    Paris, France

  • AP-PH Hopital Cochin service de pédiatrie

    RECRUITING

    Paris, France

  • APHP Hopital Necker

    RECRUITING

    Paris, France

  • CHRU de Lille CRCM Pédiatrique

    RECRUITING

    Lille, France

  • CHU de Bordeaux - CRCM pédiatrique

    RECRUITING

    Bordeaux, France

  • CHU de Grenoble Alpes CRCM pédiatrique

    RECRUITING

    Grenoble, France

  • CHU de Limoges CRCM Limousin

    RECRUITING

    Limoges, France

  • CHU de Montpellier

    RECRUITING

    Montpellier, France

  • CHU de Nancy

    RECRUITING

    Nancy, France

  • CHU de Nice

    RECRUITING

    Nice, France

  • CHU de Rouen

    RECRUITING

    Rouen, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, France

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

    RECRUITING

    Roscoff, France

  • Hospices Civils de Lyon Service de pédiatrie, allergologie et mucoviscidose

    RECRUITING

    Lyon, France

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