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RecruitingNCT05653011Updated Apr 24, 2026

Predictors of Prognosis in IBD Patients

An observational study in Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Seoul National University Bundang Hospital · Observational

From the registry’s dates

  • Started Mar 2013; still recruiting 13 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Inflammatory Bowel Diseases
  • Ulcerative Colitis
  • Crohn Disease

Keywords

  • inflammatory bowel disease
  • ulcerative colitis
  • crohn's disease
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In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's planned enrollment of 100 is below the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who visited Seoul National University Bundang Hospital.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Control group

    Patients who are not diagnosed with inflammatory bowel disease and have colitis.

    Other: Endoscopic biopsy

  • 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

  • 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

Interventions

  • OtherEndoscopic 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.

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What researchers measure

Primary outcomes

  1. The expression level of multiple markers associated with IBD activity or prognosis

    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.

    Time frame: baseline (at the time of enrollment)

Secondary outcomes

  1. The change of expression level of multiple markers associated with IBD activity or prognosis

    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)

    Time frame: Every 2 years. The examination will be suspended when treatment was ended.

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 463-707, South Korea
    • Nayoung Kim, M.D.,Ph.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • Jun YK, Kim N, Yoon H, Park JH, Kim HK, Choi Y, Lee JA, Shin CM, Park YS, Lee DH. Molecular Activity of Inflammation and Epithelial-Mesenchymal Transition in the Microenvironment of Ulcerative Colitis. Gut Liver. 2024 Nov 15;18(6):1037-1047. doi: 10.5009/gnl230283. Epub 2024 Feb 22. PubMed 38384179 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05653011
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Nayoung Kim (professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 15, 2022
Start date
Mar 11, 2013
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 24, 2026

Study contacts

Yu kyung Jun, M.D., Ph.D
Contact
juk0220@nate.com
+ 82-31-787-7845
Nayoung Kim, M.D., Ph.D
study chair · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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