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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2016 |
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Main ID: |
NCT00215020 |
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Date of registration:
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15/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease
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Scientific title:
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Phase I Evaluation of Urinary Isoprostane Levels in Pediatric Patients With Inflammatory and Non-Inflammatory Gastrointestinal Disease |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00215020 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul A. Rufo, MD, MMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Boston |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Crohn's Disease
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Inflammatory Bowel Disease
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Secondary ID(s)
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03-04-060
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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