Effects of elexacaftor-tezacaftor-ivacaftor on metabolism, epigenetics, and gut bacteria in people with cystic fibrosis

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 observational, multicenter Italian project will enroll people with cystic fibrosis who are about to begin ETI therapy and will collect biological samples before and after treatment initiation. Researchers will analyze blood for metabolic and epigenetic markers and stool samples to profile fecal microbiota composition. Serial sampling and laboratory analyses will be used to detect treatment-associated shifts in metabolism, DNA methylation or other epigenetic signals, and microbial community structure. The goal is to map systemic and gut-level changes that occur as patients start ETI under real-world clinic conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico
  Florence, Italy Recruiting
• Centro per la Fibrosi Cistica, Azienda Universitaria Ospedaliera Consorziale Policlinico
  Bari, Bari, Italy Not yet recruiting
• Dipartimento di Pediatria, Centro Fibrosi Cistica, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  Milan, Milano, Italy Not yet recruiting
• Unità Pediatrica, Dipartimento di Scienze Mediche Traslazionali, Centro di Riferimento Regionale per la Fibrosi Cistica, Università degli Studi di Napoli Federico II
  Naples, Napoli, Italy Not yet recruiting
• Ospedale pediatrico Bambino Gesù, IRCCS, Dipartimento Pediatrico Universitario Ospedaliero, UOC Pneumologia e Fibrosi Cistica
  Roma, Roma, Italy Not yet recruiting
• Centro per la Fibrosi Cistica, Ospedale Infantile Regina Margherita
  Torino, Torino, Italy Not yet recruiting

Study contacts

• Study coordinator: Vito Terlizzi, Medical Doctor
• Email: vito.terlizzi@meyer.it
• Phone: +39 055 566 2474

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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.