AI System for Detection and Characterization of Chronic Enteropathies

Coeliac disease (CD) is an immune-mediated enteropathy leading to small intestinal mucosal atrophy. Diagnosis relies on serology and duodenal biopsies, but it can be complicated by patchy lesions and differential diagnosis with Non-Celiac Enteropathies (NCEs). This multicenter observational study aims to develop and validate an Artificial Intelligence (AI) system to detect and characterize small bowel mucosal atrophy and other pathological findings using endoscopic imaging. The study involves a retrospective phase for training the AI model and a prospective phase to validate its diagnostic accuracy compared to standard human assessment.

NCT Number	NCT07387185
Lead Sponsor	Istituti Clinici Scientifici Maugeri SpA Collaborators: Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Valduce Hospital, Azienda Ospedale Università Padova, Padova, IRCCS Azienda Ospedaliero-Universitaria di Bologna, ASST Cremona, Cremona, A.O.U. Città della Salute e della Scienza, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Asst Degli Spedali Civili Di Brescia, IRCCS Policlinico San Donato, Milano, Azienda Socio-Sanitaria Territoriale (ASST) di Pavia, Azienda Unità Sanitaria Locale della Romagna, ASST Lecco, Lecco, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano, Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK
Conditions	Celiac Disease, Small Bowel Mucosal Atrophy or Lesions, Non-celiac Enteropathies
Enrollment	380 participants
Start Date	2025-02-20
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-04