Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Heidelberg University

Overview

The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Ulcerative Colitis

Interventions

retarded release phosphatidylcholineDRUG

2g daily, given orally QTD

Eligibility

Sex: ALLMin age: 15 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of ulcerative colitis in remission (CAI 3 or less) * signed letter of content * no steroids or immunosupressants in the last 6 weeks * at least 5 relapses in the last 3 years * last relapse was 8 months ago or less * complete colonoscopy at entry Exclusion Criteria: * pregnancy or breast feeding * steroids or immunosuppressants * acute episode of UC * condition after complete or partial colektomy * known intolerance to mesalazin * severe medical disease other than colitis

Locations (1)

Medical Hospital - University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

rate of relapses

relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days

Secondary Outcomes

time to the first relapse

amount of relapses per year

endoscopic index

histolgical score

life quality

side effects

Data from ClinicalTrials.gov

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