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Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease

NCT00215020 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2016-01-27

No results posted yet for this study

Summary

Isoprostanes are compounds that are produced as a result of oxidative damage to cell membranes. Elevated tissue, serum, and urinary isoprostane levels have been described in a number of inflammatory diseases. The goal of this study is to determine utility of measuring urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory gastrointestinal disease. Urine samples will be collected from pediatric patients undergoing procedures in the Children's Hospital endoscopy unit. Clinical disease activity will be assessed using a standardized clinical disease activityiIndex. Gross endoscopic and histologic findings will be graded. Previously obtained laboratory studies will also be recorded. Urinary Isoprostane levels will be determined using a commercially available assay. Isoprostane levels will be compared across conditions (IBD vs. non-inflammatory, Crohn's disease vs. ulcerative colitis) and tested for statistical significance. Similarly, disease severity and urinary isoprostane levels will be assessed. The sensitivity, specificity, and positive and negative predictive values of elevated urinary isoprostane levels at discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal disease will be calculated.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Paul A. Rufo, MD, MMSc · Boston Children's Hospital

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215020 on ClinicalTrials.gov