Ulcerative Colitis
Conditions
Keywords
Ulcerative, Colitis, PGE-M, fecal calprotectin, disease biomarkers
Brief summary
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.
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).
Interventions
PROCEDUREUrinary PGEm level
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
PROCEDUREfecal calprotectin
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.
Sponsors
Procter and Gamble
Vanderbilt University
Study design
Allocation
NON_RANDOMIZED
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine for PGEm Levels | Day of colonoscopy procedure |
Secondary
| Measure | Time frame |
|---|---|
| Blood for CRP | Day 1 |
| Stool for fecal calprotectin | At least 2 days before colonoscopy procedure (prior to bowel prep) |
| MAYO disease activity score | Day of colonoscopy procedure |
| Routine colonoscopy for assessment of disease activity | 1-3 weeks after consent |
Countries
United States
Outcome results
None listed