Crohn's Disease
Conditions
Keywords
Crohn's Disease
Brief summary
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.
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 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.
Interventions
PROCEDUREFecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
PROCEDUREUrinary PGE-M Level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
Sponsors
UCB Pharma
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine for PGE-M levels | Day of colonoscopy procedure |
Secondary
| Measure | Time frame |
|---|---|
| Blood for C-reactive protein (CRP) levels | Day 1 |
| Stool for fecal calprotectin | Prior to colonoscopy procedure (before beginning bowel prep) |
| Routine colonoscopy for assessment of disease activity | 1-3 weeks from consent |
| Harvey-Bradshaw index disease activity score | Day of colonoscopy procedure |
Countries
United States
Outcome results
None listed