Predictors of Prognosis in IBD Patients
Observational · No treatment assigned · 1 site · Seoul National University Bundang Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2013-03-11.
- Main results expected around 2026-10-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in South Korea.
Main thing being measured
- The expression level of multiple markers associated with IBD activity or prognosis (baseline (at the time of enrollment))
In the researchers’ words
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease |
| Lead sponsor | Seoul National University Bundang Hospital |
| Enrollment | 100 (estimated) |
| Start date | 2013-03-11 |
| Primary completion (est.) | 2026-10-31 |
| First posted | 2022-12-15 |
| Last updated | 2026-04-24 |
| Official title | Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal |
| ClinicalTrials.gov ID | NCT05653011 |
Interventions
- Endoscopic biopsy (Other)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | South Korea | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.