- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215020
Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease
January 26, 2016 updated by: Paul Rufo, Boston Children's Hospital
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with known or suspected IBD.
Description
Inclusion Criteria:
- Patients scheduled for endoscopic evaluation (upper endoscopy, colonoscopy or sigmoidoscopy)
- Patients currently completing lactose hydrogen breath tests (LHBT)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
January 27, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-04-060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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