Predictors of Prognosis in IBD Patients

Recruiting

• Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Other: Endoscopic biopsy

• Registration Number: NCT05653011
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2013-03-11
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TNF-alpha Inhibitor-naive IBD group	Endoscopic biopsy	Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment.
TNF-alpha Inhibitor-treated IBD group	Endoscopic biopsy	Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment.
Control group	Endoscopic biopsy	Patients who are not diagnosed with inflammatory bowel disease and have colitis.

Primary Outcome Measures

Name	Time	Method
The expression level of multiple markers associated with IBD activity or prognosis	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 Outcome Measures

Name	Time	Method
The change of expression level of multiple markers associated with IBD activity or prognosis	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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of