Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)NCT07590271

Research on the Whole Process of AI Intelligent Management System for the Diagnosis and Treatment of Inflammatory Bowel Diseases

An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Crohn's Disease (CD), run by Taichung Veterans General Hospital at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn's Disease (CD), Ulcerative Colitis (UC)
How many people: 4,500 participants
Where: 1 siteTaiwan
Study dates: 1 Jun 2026to 31 Dec 2027
Phase: Observational

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: IBD and non-IBD Patients

Who may be able to join

Patients diagnosed with IBD (K50.00 to K51.919) within the specified time interval.
Patients never diagnosed with IBD (K50.00 to K51.919) within the specified time interval.

Who cannot join

Patients not within the specified time interval Deceased patients
Patients not within the specified time interval Deceased patients Patients with fewer than 5 hospital visits

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site

Taichung Veterans General Hospital
Taichung, Xitun Dist., 407219
Chung Hsin Chang, 886-4-23592525 ext. 3302, chunghsin@vghtc.gov.tw

Other trials in Taiwan

About this study

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic immune-mediated disorder requiring long-term management. Clinically, IBD may involve recurrent intestinal inflammation, ulcer formation, and complications such as strictures and fistulas. The etiology of IBD is associated with immune dysregulation, gut microbiome imbalance, and genetic susceptibility. Its clinical manifestations are heterogeneous; early symptoms such as abdominal pain, diarrhea, weight loss, hematochezia, or anemia often resemble gastroenteritis, irritable bowel syndrome, or infectious enterocolitis, leading to misdiagnosis and delayed diagnosis. According to international studies, the interval between initial symptom onset and confirmed diagnosis can range from several months to years, during which untreated disease progression increases the risks of hospitalization, surgery, bowel strictures, and fistulizing complications, resulting in significant impacts on patient quality of life.

This study adopts a retrospective design, analyzing our hospital's electronic medical record data from 2023 to 2025.The objective is to evaluate the performance and feasibility of an artificial intelligence (AI) model-developed and incorporating natural language processing (NLP) and phenotypic recognition algorithms-in supporting early identification and diagnosis of IBD. The model has been validated in multiple European healthcare systems and is capable of recognizing high-risk phenotypic clusters from large-scale structured and unstructured medical data. This study represents the first application of this AI technology in the Taiwanese IBD population. All data processing will occur within a de-identified and secure computing environment to ensure data privacy and information security.

The study will compare AI-generated diagnostic suggestions derived from medical records with actual clinical diagnoses to assess consistency and accuracy. The model's performance across different clinical characteristics, disease severity levels, and stages of illness will also be examined. In addition, statistical metrics such as precision and recall will be used to generate PRC curves for determining the optimal diagnostic threshold. The outcomes of this study are expected to validate the potential of AI technology in facilitating early recognition, accelerating diagnosis, and supporting clinical decision-making for IBD. The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life.

Objective 1：To retrospectively analyze the clinical characteristics and diagnostic pathways of patients with IBD (CD/UC).

Objective 2：To evaluate the performance of the AI model in identifying and providing diagnostic suggestions for high-risk IBD cases.

Objective 3：To compare the accuracy and consistency between AI-generated diagnostic suggestions and actual clinical diagnoses.

Conditions: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn's Disease (CD), Ulcerative Colitis (UC), Artificial Intelligence (AI), Natural Language Processing (NLP)
Medical subject headings: Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

developing localized AI models for IBD
The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life.
Measured: No direct participant involvement; retrospective chart review of medical records from 2023 to 2025 only.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202631 Dec 2027

First posted15 May 2026
Study start1 Jun 2026 (estimated)
Primary completion1 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
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: Case-control
Time perspective: Retrospective
Enrolment: 4,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07590271
Sponsor's protocol ID: CE26157A
Status last verified: May 2026
First submitted: 11 May 2026
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang HH, Wang YH, Liang CW, Li YC. Assessment of Deep Learning Using Nonimaging Information and Sequential Medical Records to Develop a Prediction Model for Nonmelanoma Skin Cancer. JAMA Dermatol. 2019 Nov 1;155(11):1277-1283. doi: 10.1001/jamadermatol.2019.2335.
PubMed 31483437
Nguyen PA, Syed-Abdul S, Iqbal U, Hsu MH, Huang CL, Li HC, Clinciu DL, Jian WS, Li YC. A probabilistic model for reducing medication errors. PLoS One. 2013 Dec 3;8(12):e82401. doi: 10.1371/journal.pone.0082401. eCollection 2013.
PubMed 24312659
Le Berre C, Ricciuto A, Peyrin-Biroulet L, Turner D. Evolving Short- and Long-Term Goals of Management of Inflammatory Bowel Diseases: Getting It Right, Making It Last. Gastroenterology. 2022 Apr;162(5):1424-1438. doi: 10.1053/j.gastro.2021.09.076. Epub 2022 Jan 4.
PubMed 34995529
Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.
PubMed 33359090

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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