Predictors of Prognosis in IBD Patients

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653011
• Other study ID #: B-1305-201-001
• Status: Recruiting
• Start date: March 11, 2013
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Seoul National University Bundang Hospital
• Contact: Yu kyung Jun, M.D., Ph.D
• Phone: + 82-31-787-7845
• Email: juk0220[@]nate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a inhibitor-naive IBD group: IBD patients who do not have a history of TNF-a inhibitor treatment

• TNF-a inhibitor-treated IBD group: IBD patients who are treated with TNF-a inhibitor

Exclusion Criteria:

• Age under 18 years

• Patients who were treated with antibiotics or probiotics within the last 3 months

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (at the time of enrollment)
Secondary	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)	Every 2 years. The examination will be suspended when treatment was ended.