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

Purpose

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.

Condition	Intervention
Ulcerative Colitis	Procedure: Urinary PGEm level Procedure: fecal calprotectin

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Ulcerative Colitis

Drug Information available for:

Dinoprostone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Official Title:	Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood for CRP [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ] [ Designated as safety issue: No ]
MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	November 2006
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fecal calprotectin and urinary PGEm levels will be tested on all participants.	Procedure: Urinary PGEm level Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis. Procedure: fecal calprotectin Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Exclusion Criteria:

Unable to give consent
Crohn's disease
Does not meet inclusion criteria
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409396

Locations


United States, Tennessee
	Vanderbilt University Medical Center
	Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Procter and Gamble

Investigators


Principal Investigator:	David A. Schwartz, MD	Vanderbilt University

More Information

Responsible Party:	VUMC ( David A Schwartz, MD )
Study ID Numbers:	Urinary PGE-M UC
First Received:	December 5, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00409396
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Ulcerative

Colitis

PGE-M

fecal calprotectin

disease biomarkers

Study placed in the following topic categories:

Dinoprostone

Digestive System Diseases

Gastrointestinal Diseases

Ulcer

Colonic Diseases

Inflammatory Bowel Diseases

Colitis, Ulcerative

Intestinal Diseases

Gastroenteritis

Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Vanderbilt University Procter and Gamble
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00409396