Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00409396

Ulcerative Colitis

COMPLETED NA

Specific microRNAs as Potential Biomarker for Inflammatory Bowel Disease

NCT03698500

Crohn's Disease Ulcerative Colitis

UNKNOWN NA

Urinary PGE-MUM (PROSTAGLANDIN E-MAJOR URINARY METABOLITE) as Inflammatory Marker in Chronic Inflammatory Bowel Disease

NCT05171452

Inflammatory Bowel Diseases

COMPLETED

Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis

NCT00586599

Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

COMPLETED NA

Contrast-Enhanced Ultrasound in Human Crohn's Disease

NCT02061163

Crohn's Disease

WITHDRAWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The available clinical measures of Crohn's disease 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 inflammatory bowel disease (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 Crohn's 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Fecal calprotectin and urinary PGE-M levels will be tested on all participants.

Group Type EXPERIMENTAL

Fecal calprotectin

Intervention Type PROCEDURE

Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.

Urinary PGE-M Level

Intervention Type PROCEDURE

Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fecal calprotectin

Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.

Intervention Type PROCEDURE

Urinary PGE-M Level

Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Outpatient male or female 18 years or older
* Confirmed diagnosis of Crohn's disease
* Informed consent obtained
* Able to give blood, urine and stool samples
* Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care

* Pregnant