Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Heidelberg University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- complete steroid reduction
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis.
The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.
Detailed Description
Design: Prospective, randomized, placebo-controlled, double-blinded study. Population: 60 patients with chronic active ulcerative colitis and steroid dependency Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months. Main criteria: complete steroid reduction
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Letter of Content
- •diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence)
- •chronic active and steroid dependent course over at least 4 months (CAI \> 4, EAI \> 4)
Exclusion Criteria
- •infectious colitis
- •toxic megacolon
- •ulcerative proctitis or less than 20cm inflamed
Outcomes
Primary Outcomes
complete steroid reduction
Secondary Outcomes
- remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis