Predictors of Prognosis in IBD Patients

April 23, 2026 updated by: Nayoung Kim, Seoul National University Bundang Hospital

Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal

A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory disease composed of two types: Crohn's disease (CD) and ulcerative colitis (UC). It is difficult to cure the IBD completely and patients with clinical or endoscopic remission can worsen again. Therefore, predicting the prognosis of patients with IBD is still challenging.

Endoscopic biopsied samples and blood samples from IBD patients and non-IBD controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. The correlation between expression levels of multiple markers and prognosis will be evaluated.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yu kyung Jun, M.D., Ph.D
  • Phone Number: + 82-31-787-7845
  • Email: juk0220@nate.com

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Nayoung Kim, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who visited Seoul National University Bundang Hospital.

Description

Inclusion Criteria:

  • control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)
  • TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment
  • TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor

Exclusion Criteria:

  • Age under 18 years
  • Patients who were treated with antibiotics or probiotics within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Patients who are not diagnosed with inflammatory bowel disease and have colitis.
Other: Endoscopic biopsy

When patients have colonoscopy or sigmoidoscopy for evaluation of their disease course, biopsied samples are collected.

In the IBD group, samples are obtained at endoscopically active and/or inactive lesions. In the control group, samples are obtained at endoscopically normal lesions.
TNF-alpha Inhibitor-naive IBD group
Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment.
Other: Endoscopic biopsy

When patients have colonoscopy or sigmoidoscopy for evaluation of their disease course, biopsied samples are collected.

In the IBD group, samples are obtained at endoscopically active and/or inactive lesions. In the control group, samples are obtained at endoscopically normal lesions.
TNF-alpha Inhibitor-treated IBD group
Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment.
Other: Endoscopic biopsy

When patients have colonoscopy or sigmoidoscopy for evaluation of their disease course, biopsied samples are collected.

In the IBD group, samples are obtained at endoscopically active and/or inactive lesions. In the control group, samples are obtained at endoscopically normal lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expression level of multiple markers associated with IBD activity or prognosis
Time Frame: baseline (at the time of enrollment)
The expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc.
baseline (at the time of enrollment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of expression level of multiple markers associated with IBD activity or prognosis
Time Frame: Every 2 years. The examination will be suspended when treatment was ended.
The change of expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc. (compared to results 2 year ago)
Every 2 years. The examination will be suspended when treatment was ended.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Chair: Nayoung Kim, M.D., Ph.D, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2013

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1305-201-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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