A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.

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Detailed Description

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The available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of UC disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Fecal calprotectin and urinary PGEm levels will be tested on all participants.

Group Type EXPERIMENTAL

Urinary PGEm level

Intervention Type PROCEDURE

Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.

fecal calprotectin

Intervention Type PROCEDURE

Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

Interventions

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Urinary PGEm level

Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.

Intervention Type PROCEDURE

fecal calprotectin

Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Outpatient male or female 18 years or older
* Confirmed diagnosis of ulcerative colitis
* Informed consent obtained
* Able to give blood, urine and stool samples
* Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care

* Pregnant