Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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.

Condition Phase
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase I Evaluation of Urinary Isoprostane Levels in Pediatric Patients With Inflammatory and Non-Inflammatory Gastrointestinal Disease

Resource links provided by NLM:


Further study details as provided by Boston Children’s Hospital:

Biospecimen Retention:   Samples Without DNA
Specimens stored at -80 in the Center for IBD at Boston Children's Hospital.

Enrollment: 150
Study Start Date: September 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with known or suspected IBD.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215020

Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Crohn's and Colitis Foundation
Investigators
Principal Investigator: Paul A. Rufo, MD, MMSc Boston Children’s Hospital
  More Information

Responsible Party: Paul Rufo, Assistant Professor of Pediatrics, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00215020     History of Changes
Other Study ID Numbers: 03-04-060 
Study First Received: September 15, 2005
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Boston Children’s Hospital:
Isoprostanes

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Gastroenteritis
Digestive System Diseases
Colitis
Colonic Diseases

ClinicalTrials.gov processed this record on December 07, 2016