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

NCT00215020 | Completed

• 1 other identifier: 03-04-060
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Keywords

Isoprostanes

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected IBD.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Patients with active Reactive Airway Disease (RAD)/Asthma.
• Patients with heart disease
• Smokers
• Patients with Connective tissue diseases (Scleroderma, Lupus, etc)
• Patients with Renal Disease
• Subjects must have had recent biochemical studies completed (including CBC, albumin, and ESR) within one month of receipt of sample.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens stored at -80 in the Center for IBD at Boston Children's Hospital.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Paul A. Rufo, MD, MMSc

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: January 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)