Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
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About
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.
Full 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 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.
Enrollment
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
159 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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