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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
University Heidelberg - Medical Department 4 - Gastroenterology
Heidelberg, Germany
complete steroid reduction
remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.