Ulcerative Colitis Clinical Trial
Official title:
Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
The purpose of this study is to find the optimal dose of retarded release
Phosphatidylcholine in the most severe form of ulcerative colitis.
The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the
colonic mucus layer. The background of the study is the finding, that the
phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to
healthy controls and patients with Crohn´s disease. The content was meuasured in
non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic
PC is an effective method.
Design: prospective, randomized, double-blind, dose-finding study with retarded
phosphatidylcholine.
Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to
historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic
active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at
least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.
Exclusion criteria: Pregnancy & fulminant course
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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