Prospective, controlled, multicenter trial on the prognostic significance of video capsule endoscopy (Capsule Endoscopy) of the small intestine in ulcerative colitis
Not Applicable
- Conditions
- K51Ulcerative colitis
- Registration Number
- DRKS00009235
- Lead Sponsor
- CED Service GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
Ulcerative colitis patients who were enrolled in the study BioColitis (Cu with an early history - enrollment <2 years after initial diagnosis or initiation of a TNF-alpha therapy)
Exclusion Criteria
Age at inclusion of small 18 and larger 80 years
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of pathological findings in the small intestine of CU patients using video capsule endoscopy (VCE).
- Secondary Outcome Measures
Name Time Method 1. predictors and prognostic significance of detectable intestinal changes<br> 2. characterization of factors influencing the natural history of UC<br> 3. Predictive significance of the small intestine changes to therapy need and the therapeutic effect of a TNF-alpha therapy<br> 4. proportion of UC patients with a complicated course (steroid dependency or refractary, proctocolectomy) with a detection of small bowel changes<br> 5. Genetic characterization of CU patients with and without changes in the small intestine using VCE