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Trikafta's hidden effects: new study probes metabolism and microbiome in CF patients

NCT ID NCT07363304

Knowledge-focused Sponsor: Meyer Children's Hospital IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 150 cystic fibrosis patients starting the drug combination Trikafta (ETI) to see how it affects their metabolism, DNA methylation, and gut bacteria. Researchers will measure blood fats, sugars, and immune markers, and link them to drug levels. The goal is to understand why some patients develop side effects like high cholesterol or liver problems, and to find ways to personalize dosing.

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 (Trikafta/Kaftrio)
What this could lead to
If successful, this could help doctors personalize ETI dosing to reduce side effects like high cholesterol or liver issues, improving long-term care for cystic fibrosis patients.
What could go wrong
This is an observational study, not a treatment trial. It won't prove if ETI works or is safe, only track changes in the body. 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.

Participants

About 150 people

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

Started

Dec 2025

Expected to finish

Apr 2029

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.

Who is studied

The study will enroll patients with CF pre and post ETI therapy, followed up at included Italian CF centers.

Ages

2 years and older

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: * Patients with CF, of any age, about to start ETI therapy, in accordance with marketing authorization Italian legislative directives, followed at the participating CF centers. * Obtaining informed consent. Exclusion Criteria: * CF patients not in ETI therapy and CF patients already in ETI therapy.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

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

Cystic fibrosis (CF)

How to take part

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

  1. The places running it

    6 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

  • Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico

    RECRUITING

    Florence, 5016, Italy

  • Centro per la Fibrosi Cistica, Azienda Universitaria Ospedaliera Consorziale Policlinico

    NOT_YET_RECRUITING

    Bari, Bari, Italy

  • Centro per la Fibrosi Cistica, Ospedale Infantile Regina Margherita

    NOT_YET_RECRUITING

    Torino, Torino, Italy

  • Dipartimento di Pediatria, Centro Fibrosi Cistica, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, Milano, Italy

  • Ospedale pediatrico Bambino Gesù, IRCCS, Dipartimento Pediatrico Universitario Ospedaliero, UOC Pneumologia e Fibrosi Cistica

    NOT_YET_RECRUITING

    Roma, Roma, Italy

  • Unità Pediatrica, Dipartimento di Scienze Mediche Traslazionali, Centro di Riferimento Regionale per la Fibrosi Cistica, Università degli Studi di Napoli Federico II

    NOT_YET_RECRUITING

    Naples, Napoli, Italy

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