Predictors of Prognosis in IBD Patients

Seoul National University

Status: Enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Endoscopic biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05653011

B-1305-201-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Control group

Description:

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

Treatment:

Other: Endoscopic biopsy

TNF-alpha Inhibitor-naive IBD group

Description:

Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment.

Treatment:

Other: Endoscopic biopsy

TNF-alpha Inhibitor-treated IBD group

Description:

Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment.

Treatment:

Other: Endoscopic biopsy