Skip to content

Predictors of Prognosis in IBD Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05653011
Enrollment
100
Registered
2022-12-15
Start date
2013-03-11
Completion date
2026-12-31
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis

Keywords

inflammatory bowel disease, ulcerative colitis, crohn's disease

Brief summary

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

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.

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.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
The expression level of multiple markers associated with IBD activity or prognosisbaseline (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

MeasureTime frameDescription
The change of expression level of multiple markers associated with IBD activity or prognosisEvery 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)

Countries

South Korea

Contacts

CONTACTYu kyung Jun, M.D., Ph.D
juk0220@nate.com+ 82-31-787-7845
STUDY_CHAIRNayoung Kim, M.D., Ph.D

Seoul National University Bundang Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026