Clinical Trials Directory

Trials / Completed

CompletedNCT00586352

Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease

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

Summary

Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in the colon. Children with inflammatory bowel disease frequently suffer from disturbances in growth, which may continue into adulthood and result in altered growth outcomes. The metabolic response to inflammatory bowel disease, including increased protein breakdown and decreased protein synthesis may play a significant role in the resulting malnutrition and growth failure from which children with inflammatory bowel disease suffer. The purpose of this study is to compare the rates of protein synthesis within the mucosal lining of the gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have normal endoscopic examinations. By comparing children with inflammatory bowel disease to normal children, we can begin to determine how alterations in protein metabolism within the lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a follow-up study will be conducted two weeks following the initiation of steroid therapy to determine its effects on protein metabolism. We hypothesize that children with active inflammatory bowel disease will have increased rates of protein synthesis in the lining of the gastrointestinal tract than patients who have normal endoscopy, and that increases in protein breakdown and protein synthesis will be improved following steroid therapy in children with newly diagnosed inflammatory bowel disease.

Conditions

Interventions

TypeNameDescription
OTHERstable isotope infusionsSubjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.

Timeline

Start date
2006-01-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2008-01-04
Last updated
2016-08-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00586352. Inclusion in this directory is not an endorsement.

Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease (NCT00586352) · Clinical Trials Directory