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Sponsors and Collaborators: |
Indiana University GlaxoSmithKline Crohn's and Colitis Foundation National Center for Research Resources (NCRR) |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00583232 |
The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has been incriminated in the mechanism of weight loss in many different chronic diseases, and causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven to be an effective therapy for ulcerative colitis.
The purpose of this study is to compare changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this study will better define the changes in nutrition status observed in these children following remission of active Crohn's disease, and potentially lead to changes in medical and nutritional management of these children.
Condition | Intervention |
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Crohn's Disease Protein Metabolism Energy Metabolism |
Other: Stable isotope infusions |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Protein and Energy Metabolism in Pediatric Crohn's Disease |
Estimated Enrollment: | 34 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Corticosteroid: Active Comparator
Subjects receiving corticosteroid therapy (1-2 mg/kg/day up to 60mg/day) with taper.
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Other: Stable isotope infusions
Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
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infliximab: Active Comparator
Subjects receiving infliximab therapy (5 mg/kg at 0, 2 and 6 weeks, followed by every 8 week therapy)
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Other: Stable isotope infusions
Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
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Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female children between the ages of six and eighteen years of age with recurrence of active Crohn's disease, determined by their primary pediatric gastroenterologist to require either:
If receiving concomitant medications, must have been on a stable regimen as follows:
Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
Exclusion Criteria:
Contact: Steven J Steiner, MD | 317-274-3774 |
United States, Indiana | |
Indiana University-Riley Hospital for Children | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Steven J Steiner, MD |
Principal Investigator: | Steven J. Steiner, MD | Indiana University |
Responsible Party: | Indiana University ( Steven Steiner, MD ) |
Study ID Numbers: | GCRC 1307, IRB 0506-19 |
Study First Received: | December 20, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00583232 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Pediatric Crohn's disease protein metabolism energy metabolism |
Digestive System Diseases Crohn’s disease, pediatric Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |