Clinical Trial: Protein and Energy Metabolism in Pediatric Crohn's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protein and Energy Metabolism in Pediatric Crohn's Disease

Brief 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.


Detailed Summary:
Sponsor: Indiana University

Current Primary Outcome: Compare whole body and splanchnic protein kinetics and balance in response to corticosteroid and anti-TNF-alpha therapies in the fasting state and during enteral nutrition infusion. [ Time Frame: Week 0, 2 and 14 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on resting and total energy expenditure. [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on free fatty acid metabolism [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on quality of life [ Time Frame: Week 0, 2, and 14 ]
  • Comparing the effects of corticosteroid and anti-TNF-alpha therapies on bone turnover and bone density [ Time Frame: Week 0,2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on body composition. [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on cytokines known to be altered in inflammatory bowel disease. [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on vascular endothelial function. [ Time Frame: Week 0, 2 and 14 ]


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: December 20, 2007
Date Started: February 2006
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017