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

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ClinicalTrials.gov Identifier: NCT00409396
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : June 9, 2015
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Procedure: Urinary PGEm level Procedure: fecal calprotectin Not Applicable

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).


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease
Study Start Date : November 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ]

Secondary Outcome Measures :
  1. Blood for CRP [ Time Frame: Day 1 ]
  2. Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ]
  3. MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ]
  4. Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: David Schwartz, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00409396     History of Changes
Other Study ID Numbers: Urinary PGE-M UC
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: November 2014

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

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