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| Sponsors and Collaborators: |
Indiana University ASPEN Rhoads Research Foundation |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00586807 |
Purpose
The metabolic response to ulcerative colitis, 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 determine changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) in children with ulcerative colitis. Performing this study will better define the changes in nutrition status observed in these children following remission of active ulcerative colitis, and potentially lead to changes in medical and nutritional management of these children
| Condition | Intervention |
|---|---|
|
Ulcerative Colitis Protein Metabolism Energy Expenditure |
Other: Stable amino acid isotopes |
| Study Type: | Interventional |
| Study Design: | Basic Science, Open Label, Single Group Assignment |
| Official Title: | Metabolic Response to Infliximab in Pediatric Ulcerative Colitis |
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Infliximab
Subjects on infliximab
|
Other: Stable amino acid isotopes
Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.
|
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Indiana University- Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Steven J Steiner, MD | Indiana University |
More Information
| Responsible Party: | Indiana University ( Steven J. Steiner, MD ) |
| Study ID Numbers: | GCRC 1274, IRB #0503-23 |
| Study First Received: | December 21, 2007 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00586807 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Ulcerative colitis pediatrics UC protein metabolism energy expenditure |
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Digestive System Diseases Infliximab Gastrointestinal Diseases Pediatric Ulcerative Colitis Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
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Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |