AI System for Detection and Characterization of Chronic Enteropathies

Development and Validation of an Artificial Intelligence System for Detection and Characterization of Small Bowel Mucosal Atrophy in Celiac Disease and Non-Celiac Enteropathies: A Multicenter Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Celiac Disease; Small Bowel Mucosal Atrophy or Lesions; Non-celiac Enteropathies

Detailed Description

The study is a multicenter observational non-profit study with a total expected duration of 36 months. It aims to address the challenges in diagnosing CD and NCEs, specifically the subjective nature of endoscopic evaluation and inter-observer variability.

The study proceeds in two phases:

1. Model Development (Retrospective): Training of Deep Learning algorithms on anonymized endoscopic images/videos to identify mucosal atrophy and other lesions (e.g., angiodysplasia, ulcers, polyps).
2. Validation (Prospective): Enrolling patients undergoing small bowel endoscopy to validate the AI system's performance.

The system aims to provide analysis to assist endoscopists, reducing missed lesions and improving diagnostic accuracy.

Validation of the AI system will be performed offline on recorded anonymized endoscopy videos collected prospectively during the validation phase.

• Study Type: Observational
• Enrollment (Estimated): 380

Contacts and Locations

• Study Contact: Name: Federico Biagi, MD; Phone Number: +39 0382592695; Email: federico.biagi@icsmaugeri.it

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Recruiting
      • ICS Maugeri IRCCS
      • Contact: Federico Biagi, MD; Phone Number: +39 0382592695; Email: federico.biagi@icsmaugeri.it
      • Principal Investigator: Federico Biagi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy) for suspected or known celiac disease, non-celiac enteropathies or other small bowel conditions

Description

Inclusion Criteria:

• Adult patients (age ≥18 years).
• Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)

Exclusion Criteria:

• Inability to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Enteropathy Cohort (CD/NCE); Adult patients (>=18 years) with suspected or confirmed Celiac Disease or Non-Celiac Enteropathies undergoing small bowel endoscopy.
Control Cohort; Adult patients (>=18 years) undergoing small bowel endoscopy who do not have enteropathy or other small bowel pathological lesions (negative controls).
Other Small Bowel Lesion Cohort; Adult patients (>=18 years) undergoing small bowel endoscopy who who do not have Celiac Disease or Non-Celiac Enteropathies but have other small bowel pathological lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance of the AI System	Evaluation of Accuracy, Sensitivity, and Specificity of the AI system in detecting intestinal mucosal atrophy and other major pathological findings compared to the gold standard (histology/expert consensus).	Through study completion (36 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Diagnostic Performance (No AI-assistance vs AI-assisted)	Comparison of accuracy, sensitivity, and specificity of gastroenterologists performing assessment with and without the assistance of the AI system.	Through study completion (36 months)
Inter-observer Agreement	Measurement of agreement between the AI system and expert gastroenterologists in evaluating the extent of mucosal atrophy.	Through study completion (36 months)

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; Ospedale Valduce, Como; Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; ASST Cremona, Cremona; Azienda Ospedale Università Padova, Padova; Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino; Fondazione Poliambulanza Istituto Ospedaliero, Brescia; ASST degli Spedali Civili di Brescia , Brescia; IRCCS Policlinico San Donato, Milano; Azienda Socio-Sanitaria Territoriale (ASST) di Pavia; Azienda Unità Sanitaria Locale della Romagna, Ravenna; ASST Lecco, Lecco; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano; Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopy; Artificial Intelligence; Deep Learning; Small Bowel; Computer-Aided Diagnosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID Numbers: CTSPV36-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No