Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05653011

Predictors of Prognosis in IBD Patients

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location status: Recruiting

Location contact

Nayoung Kim, M.D.,Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic biopsy

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Yu kyung Jun, M.D., Ph.D

CONTACT

[email protected]

+ 82-31-787-7845

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.