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

This study is ongoing, but not recruiting participants.
UCB Pharma
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University
ClinicalTrials.gov Identifier:
First received: July 2, 2007
Last updated: May 6, 2016
Last verified: May 2016
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.

Condition Intervention
Crohn's Disease
Procedure: Fecal calprotectin
Procedure: Urinary PGE-M Level

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ] [ Designated as safety issue: No ]
  • Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ] [ Designated as safety issue: No ]
  • Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2007
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Procedure: Fecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
Procedure: Urinary PGE-M Level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Detailed Description:

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 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.


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

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

Exclusion Criteria:

  • Unable to give consent
  • Ulcerative colitis
  • Does not meet inclusion criteria
  • Pregnant
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00496548

United States, Tennessee
GI Clinical Research; Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2285
Sponsors and Collaborators
Vanderbilt University
UCB Pharma
Principal Investigator: David A. Schwartz, MD Vanderbilt University
  More Information

Responsible Party: David Schwartz, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00496548     History of Changes
Other Study ID Numbers: Urinary PGE-M CD 
Study First Received: July 2, 2007
Last Updated: May 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2016