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

This study has been completed.

Sponsor:

Collaborator:

Procter and Gamble

Information provided by (Responsible Party):

David Schwartz, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00409396

First received: December 5, 2006

Last updated: June 5, 2015

Last verified: November 2014

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Bowel Movement Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by David Schwartz, Vanderbilt University:

Primary Outcome Measures:

Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ]

Secondary Outcome Measures:

Blood for CRP [ Time Frame: Day 1 ]
Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ]
MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ]
Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ]


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
Experimental: 1 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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical Center

More Information


Responsible Party:	David Schwartz, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00409396 History of Changes
Other Study ID Numbers:	Urinary PGE-M UC
Study First Received:	December 5, 2006
Last Updated:	June 5, 2015

Keywords provided by David Schwartz, Vanderbilt University:


Ulcerative Colitis PGE-M fecal calprotectin disease biomarkers

Additional relevant MeSH terms:


Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases	Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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