Celiac DiseaseNCT07387185
AI System for Detection and Characterization of Chronic Enteropathies
An observational study of Celiac Disease and Small Bowel Mucosal Atrophy or Lesions, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Small Bowel Mucosal Atrophy or Lesions, Non-celiac Enteropathies
- How many people
- 380 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2025to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Adult patients (age ≥18 years).
- Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)
Who cannot join
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ICS Maugeri IRCCS
Pavia, PV, 27100
Federico Biagi, MD, 0382592695 ext. +39, federico.biagi@icsmaugeri.it
Federico Biagi, MD
About this study
Official title: 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.
Read the 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:
- 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).
- 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.
- Keywords
- Artificial Intelligence, Endoscopy, Deep Learning, Computer-Aided Diagnosis, Small Bowel
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion (36 months)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 Feb 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387185
- Sponsor's protocol ID
- CTSPV36-24
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07387185
- Acronym / sponsor ID
- CTSPV36-24
- Keywords
- Artificial Intelligence, Endoscopy, Deep Learning, Computer-Aided Diagnosis, Small Bowel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- 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
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Adult patients (age ≥18 years).
- Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)
Key exclusion criteria (1 listed)
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of the AI System
Time frame: Through study completion (36 months)
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).
2 secondary outcomes
Comparison of Diagnostic Performance (No AI-assistance vs AI-assisted)
Time frame: Through study completion (36 months)
Inter-observer Agreement
Time frame: Through study completion (36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Small Bowel Mucosal Atrophy or Lesions, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Biagi, MD (0382592695 ext. +39, federico.biagi@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of the AI System (time frame: Through study completion (36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.