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



Status:Completed
Conditions:Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease, Digestive Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 18
Updated:4/21/2016
Start Date:September 2003
End Date:June 2006

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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.

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.
We found this trial at
1
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Boston, Massachusetts 02115
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Boston, MA
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