Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259545
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : June 5, 2008
Professor Wolfgang Stremmel
Dietmar Hopp Stiftung
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Phosphatidylcholine Drug: Retarded Release Phosphatidylcholine (rPC) Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
Study Start Date : February 2003
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Lecithin
U.S. FDA Resources

Primary Outcome Measures :
  1. complete steroid reduction

Secondary Outcome Measures :
  1. remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259545

University Heidelberg - Medical Department 4 - Gastroenterology
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Professor Wolfgang Stremmel
Dietmar Hopp Stiftung
Principal Investigator: Wolfgang Stremmel, Professor Heidelberg University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00259545     History of Changes
Other Study ID Numbers: PC2
EC - L71/2003
BFARM - 402 29 17
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by Heidelberg University:
retarded phosphatidylcholine
chronic active

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases