Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Heidelberg University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Absolute change in clinical activity index (Rachmilewitz).
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic active ulcerative pancolitis
- •course more than 4 months
- •clinical index rachmilewitz 7 or more
- •endoskopic index 7 or more
Exclusion Criteria
- •steroids in the last 4 weeks
- •immunosuppressants in the last 4 weeks
- •use of topical klymsa
- •pregnancy
- •fulminant course
- •infectious colitis
Outcomes
Primary Outcomes
Absolute change in clinical activity index (Rachmilewitz).
Secondary Outcomes
- Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
- Histology and life quality are reported descriptively.