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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00409396
First received: December 5, 2006
Last updated: March 19, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention
Ulcerative Colitis
 Procedure: Urinary PGEm level
Procedure: fecal calprotectin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood for CRP [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ] [ Designated as safety issue: No ]
  • MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
  • Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ] [ Designated as safety issue: No ]
Enrollment: 35
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
 Procedure: Urinary PGEm level
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
Procedure: fecal calprotectin
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409396

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Procter and Gamble
Investigators
Principal Investigator: David A. Schwartz, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: David A Schwartz, MD, VUMC
ClinicalTrials.gov Identifier: NCT00409396     History of Changes
Other Study ID Numbers: Urinary PGE-M UC
Study First Received: December 5, 2006
Last Updated: March 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Ulcerative
Colitis
PGE-M
fecal calprotectin
disease biomarkers

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
 Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 03, 2015