Clinical Trial: Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

Brief Summary:

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

Detailed Summary:
Sponsor: Indiana University

Current Primary Outcome: Measure protein kinetics and balance in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion. [ Time Frame: Week 0 and 2 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 2. Measure energy expenditure by indirect calorimetry in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion. [ Time Frame: Week 0 and 2 ]

Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: December 21, 2007
Date Started: June 2005
Date Completion:
Last Updated: January 29, 2009
Last Verified: January 2009