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

NCT ID NCT07363304

Recruiting now Knowledge-focused Sponsor: Meyer Children's Hospital IRCCS Source: ClinicalTrials.gov ↗

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.

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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)

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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