Clinical trial NCT00259545: Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
Official title: Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Phosphatidylcholine
Keywords: retarded phosphatidylcholine
chronic active
steroid
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Professor Wolfgang Stremmel
name: Dietmar Hopp Stiftung
First posted: 2005-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: complete steroid reduction
Secondary outcomes:
measure: remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Heidelberg - Medical Department 4 - Gastroenterology
Study officials:
affiliation: Heidelberg University
name: Wolfgang Stremmel, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316.
citation: Stremmel W, Ehehalt R, Autschbach F, Karner M. Phosphatidylcholine for steroid-refractory chronic ulcerative colitis: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):603-10. doi: 10.7326/0003-4819-147-9-200711060-00004.