This trial is active, not recruiting.

Condition crohn's disease
Treatments fecal calprotectin, urinary pge-m level
Sponsor Vanderbilt University
Collaborator UCB Pharma
Start date August 2007
End date August 2015
Trial size 30 participants
Trial identifier NCT00496548, Urinary PGE-M CD


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
fecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
urinary pge-m level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Primary Outcomes

Urine for PGE-M levels
time frame: Day of colonoscopy procedure

Secondary Outcomes

Blood for C-reactive protein (CRP) levels
time frame: Day 1
Stool for fecal calprotectin
time frame: Prior to colonoscopy procedure (before beginning bowel prep)
Routine colonoscopy for assessment of disease activity
time frame: 1-3 weeks from consent
Harvey-Bradshaw index disease activity score
time frame: Day of colonoscopy procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
Principal investigator David A. Schwartz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.