Identifying Prognostic Factors in Inflammatory Bowel Disease
Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal
This study is trying to find out which signs and markers can help predict how inflammatory bowel disease will progress in people with Crohn's disease and ulcerative colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT05653011 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the clinical characteristics and potential prognostic factors in patients with inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. The research involves collecting endoscopic biopsy and blood samples from IBD patients and non-IBD controls to assess the expression levels of various markers associated with disease activity and severity. The goal is to evaluate the correlation between these markers and the prognosis of IBD patients, addressing the challenges of predicting disease outcomes.
Who should consider this trial
Good fit: Ideal candidates include IBD patients who are either naive to TNF-α inhibitors or currently receiving TNF-α inhibitor treatment, as well as non-IBD controls.
Not a fit: Patients under 18 years old or those who have received antibiotics or probiotics in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for managing inflammatory bowel disease, helping clinicians tailor treatment strategies for better patient outcomes.
How similar studies have performed: While the study's approach is focused on prognostic factors, similar studies have shown promise in identifying markers that correlate with disease outcomes in IBD.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si, Gyeonggi-do
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Yu kyung Jun, M.D., Ph.D
- Email: juk0220@nate.com
- Phone: + 82-31-787-7845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.