Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborators: Dietmar Hopp Stiftung; Professor Wolfgang Stremmel

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