Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Heidelberg University

Status and phase

Completed

Phase 2

Conditions

Phosphatidylcholine

Ulcerative Colitis

Treatments

Drug: Retarded Release Phosphatidylcholine (rPC)

Study type

Interventional

Funder types

Other

Identifiers

NCT00259545

PC2

EC - L71/2003

BFARM - 402 29 17

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

16 to 90 years old

Volunteers

No Healthy Volunteers

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