A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

Ulcerative Colitis Clinical Trial

Official title:

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409396
• Other study ID #: Urinary PGE-M UC
• Status: Completed
• Phase: N/A
• First received: December 5, 2006
• Last updated: June 5, 2015
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Urinary PGEm level
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
• fecal calprotectin
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine for PGEm Levels		Day of colonoscopy procedure	No
Secondary	Blood for CRP		Day 1	No
Secondary	Stool for fecal calprotectin		At least 2 days before colonoscopy procedure (prior to bowel prep)	No
Secondary	MAYO disease activity score		Day of colonoscopy procedure	No
Secondary	Routine colonoscopy for assessment of disease activity		1-3 weeks after consent	No