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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urinary PGEm level
fecal calprotectin
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring Ulcerative, Colitis, PGE-M, fecal calprotectin, disease biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Fecal calprotectin and urinary PGEm levels will be tested on all participants.

Outcomes

Primary Outcome Measures

Urine for PGEm Levels

Secondary Outcome Measures

Blood for CRP
Stool for fecal calprotectin
MAYO disease activity score
Routine colonoscopy for assessment of disease activity

Full Information

First Posted
December 5, 2006
Last Updated
June 5, 2015
Sponsor
Vanderbilt University
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00409396
Brief Title
A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
Official Title
Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative, Colitis, PGE-M, fecal calprotectin, disease biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
Intervention Type
Procedure
Intervention Name(s)
Urinary PGEm level
Intervention Description
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
Intervention Type
Procedure
Intervention Name(s)
fecal calprotectin
Intervention Description
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.
Primary Outcome Measure Information:
Title
Urine for PGEm Levels
Time Frame
Day of colonoscopy procedure
Secondary Outcome Measure Information:
Title
Blood for CRP
Time Frame
Day 1
Title
Stool for fecal calprotectin
Time Frame
At least 2 days before colonoscopy procedure (prior to bowel prep)
Title
MAYO disease activity score
Time Frame
Day of colonoscopy procedure
Title
Routine colonoscopy for assessment of disease activity
Time Frame
1-3 weeks after consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Schwartz, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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