Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Phase 2

Completed

• Conditions: Phosphatidylcholine; Ulcerative Colitis

• Registration Number: NCT00259545
• Lead Sponsor: Heidelberg University

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

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Study Completion: 2006-02
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-04
• Last Update Posted: 2008-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
complete steroid reduction

Secondary Outcome Measures

Name	Time	Method
remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis

Trial Locations

Locations (1)

University Heidelberg - Medical Department 4 - Gastroenterology; 🇩🇪 Heidelberg, Germany