Mediterranean diet and processed food in adults with celiac disease on a gluten-free diet

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 multicenter, cross-sectional study collects information from adults with biopsy-confirmed celiac disease who have adhered to a gluten-free diet for at least 12 months. It evaluates how closely participants’ diets align with the Mediterranean pattern and with highly processed foods, and how these patterns relate to gastrointestinal symptoms, quality of life, and nutritional status. No dietary intervention is imposed; researchers observe associations during a single study visit. The study design is observational, non-therapeutic, and leverages routine clinic visits to minimize additional burden on participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (age \> 18 years)
* Diagnosis of coeliac disease based on positive IgA tissue transglutaminase / endomysial antibodies and villous atrophy on duodenal biopsy in accordance with major international guidelines
* Strict adherence to a gluten-free diet (GFD) for at least 12 months
* Evidence of duodenal mucosal recovery on a follow-up biopsy
* Regularly attending the participating gastroenterology outpatient clinics for follow-up

Exclusion Criteria:

* Coeliac patients with poor gluten-free diet adherence and/or evidence of persistent villous atrophy on follow-up duodenal biopsy
* Patients who follow a vegetarian/vegan diet or other restrictive diets

Where it's running

• ASST Spedali Civili di Brescia, Gastroenterologia
  Brescia, Bs, Italy Recruiting
• Università degli Studi di Ferrara
  Ferrara, Fe, Italy Recruiting
• Center for Prevention and Diagnosis of Celiac Disease - Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  Milan, Michigan, Italy Recruiting
• University of Padua, Department of Surgery, Oncology and Gastroenterology
  Padua, Pd, Italy Recruiting
• Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale
  Pavia, Pv, Italy Recruiting
• ICS Maugeri SpA IRCCS, Gastroenterology Unit
  Pavia, Pv, Italy Recruiting

Study contacts

• Principal investigator: Annalisa Schiepatti, MD, PhD — ICS Maugeri SpA IRCCS
• Study coordinator: Annalisa Schiepatti, MD, PhD
• Email: annalisa.schiepatti@icsmaugeri.it
• Phone: +39 0382592695

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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.