NCT00583232

Protein and Energy Metabolism in Pediatric Crohn's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Crohn's Disease
• Protein Metabolism
• Energy Metabolism

Interventions

Type	Name	Description
DRUG	Stable isotope infusions	Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-12-31
• Last updated: 2017-03-16

Locations

1 site across 1 country: United States