Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Key facts
- Where
- Brescia, Ferrara, Milan, Padua, Pavia, and Ravenna, ItalySee the 7 sites
Where in Italy
- ASST Spedali Civili di Brescia, GastroenterologiaBrescia, ItalyContact: Chiara Ricci, MDTaking people
- Università degli Studi di FerraraFerrara, ItalyContact: Giacomo CaioTaking people
- Center for Prevention and Diagnosis of Celiac Disease - Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilan, ItalyContact: Principal InvestigatorTaking people
- University of Padua, Department of Surgery, Oncology and GastroenterologyPadua, ItalyContact: Fabiana Zingone, MD, PhDTaking people
- Fondazione IRCCS Policlinico San Matteo, SC Medicina GeneralePavia, ItalyContact: Principal InvestigatorTaking people
- ICS Maugeri SpA IRCCS, Gastroenterology UnitPavia, ItalyContact: Annalisa Schiepatti, MD, PhDTaking people
- Gastroenterology Unit, Santa Maria delle Croci HospitalRavenna, ItalyContact: Alessandro MussettoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Trial code
- NCT07915063
- Record updated
- 4 November 2026
- Original description
Coeliac disease is a lifelong autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, barley and rye, affecting about 1% of the general population. The only currently approved treatment is a strict, lifelong gluten-free diet (GFD). Although strict adherence to a gluten-free diet leads to mucosal recovery in most patients, up to 20-30% of coeliac patients continue to experience persistent gastrointestinal symptoms (such as abdominal pain, bloating, diarrhoea or constipation). Furthermore, commercially prepared gluten-free products often contain higher amounts of fat, sugar and salt, and lower amounts of fibre, protein, folate and vitamins compared with gluten-containing equivalents.Read full original descriptionShow less
MEDITERRANEAN DIET, HIGHLY PROCESSED FOODS AND THEIR IMPACT ON GASTROINTESTINAL SYMPTOMS, NUTRITIONAL STATUS AND QUALITY OF LIFE IN ADULT COELIAC DISEASE PATIENTS ON A GLUTEN FREE DIET: A MULTICENTRE CROSS-SECTIONAL STUDY
Coeliac disease is a lifelong autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, barley and rye, affecting about 1% of the general population. The only currently approved treatment is a strict, lifelong gluten-free diet (GFD). Although strict adherence to a gluten-free diet leads to mucosal recovery in most patients, up to 20-30% of coeliac patients continue to experience persistent gastrointestinal symptoms (such as abdominal pain, bloating, diarrhoea or constipation). Furthermore, commercially prepared gluten-free products often contain higher amounts of fat, sugar and salt, and lower amounts of fibre, protein, folate and vitamins compared with gluten-containing equivalents.
Conversely, the Mediterranean diet-rich in vegetables, fruits, legumes, fish, nuts and extra-virgin olive oil-is widely recognised for its benefits on cardiovascular, metabolic and gut health, as well as quality of life, in contrast to diets rich in highly or ultra-processed foods.
This multicentre cross-sectional observational study aims to evaluate whether adult coeliac patients on a long-term strict gluten-free diet whose habitual diet more closely aligns with the Mediterranean dietary pattern are less likely to experience persistent gastrointestinal symptoms and have a better quality of life and nutritional status, and conversely whether higher consumption of highly processed foods is associated with worse symptoms, poorer quality of life and less adequate nutritional status. No dietary intervention is provided as part of the study; participants complete validated questionnaires and undergo routine anthropometric and blood assessments during a single regular outpatient follow-up visit.
Inclusion: 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: 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.