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

This study has been completed.
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Paul Rufo, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00215020
First received: September 15, 2005
Last updated: January 26, 2016
Last verified: January 2016

September 15, 2005
January 26, 2016
September 2003
June 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00215020 on ClinicalTrials.gov Archive Site
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Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease
Phase I Evaluation of Urinary Isoprostane Levels in Pediatric Patients With Inflammatory and Non-Inflammatory Gastrointestinal Disease
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.
Isoprostanes are compounds 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Specimens stored at -80 in the Center for IBD at Boston Children's Hospital.
Non-Probability Sample
Patients with known or suspected IBD.
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn's Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients scheduled for endoscopic evaluation (upper endoscopy, colonoscopy or sigmoidoscopy)
  2. Patients currently completing lactose hydrogen breath tests (LHBT)

Exclusion Criteria:

  1. Patients with a previous history of HIV and/or chronic Hepatitis (or active acute hepatitis B or C). Patients will be asked about potential blood borne pathogens at the time of enrollment. No additional blood work or serologic testing outside that obtained for routine care will be required for participation in this study.
  2. Patients with a documented history of infectious diarrhea (within the past six months): Patients will be asked about previous testing for infectious diarrhea at the time of enrollment. When indicated, subjects will be asked to have primary care providers forward the results of previous testing.
  3. Patients with active Reactive Airway Disease (RAD)/Asthma.
  4. Patients with heart disease
  5. Smokers
  6. Patients with Connective tissue diseases (Scleroderma, Lupus, etc)
  7. Patients with Renal Disease
  8. Subjects must have had recent biochemical studies completed (including CBC, albumin, and ESR) within one month of receipt of sample.
Both
up to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215020
03-04-060
No
No
Not Provided
Paul Rufo, Children's Hospital Boston
Boston Children’s Hospital
Crohn's and Colitis Foundation
Principal Investigator: Paul A. Rufo, MD, MMSc Boston Children’s Hospital
Boston Children’s Hospital
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP