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NCT Number: NCT00496548

Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GI Clinical Research; Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2285, United States

About this study

The available clinical measures of Crohn's disease 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 inflammatory bowel disease (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 Crohn's 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient male or female 18 years or older
  • Confirmed diagnosis of Crohn's disease
  • Informed consent obtained
  • Able to give blood, urine and stool samples
  • Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care

Exclusion criteria

  • Unable to give consent
  • Ulcerative colitis
  • Does not meet inclusion criteria
  • Pregnant

Treatment and study plan

fecal calprotectin

Procedure

Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.

Urinary PGE-M Level

Procedure

Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Primary outcomes

  1. Urine for PGE-M levels

    Time frame: Day of colonoscopy procedure

Secondary outcomes

  1. Blood for C-reactive protein (CRP) levels

    Time frame: Day 1

  2. Stool for fecal calprotectin

    Time frame: Prior to colonoscopy procedure (before beginning bowel prep)

  3. Routine colonoscopy for assessment of disease activity

    Time frame: 1-3 weeks from consent

  4. Harvey-Bradshaw index disease activity score

    Time frame: Day of colonoscopy procedure

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jul 4, 2007
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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