Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
Information source: Indiana University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease; Ulcerative Colitis; Protein Metabolism
Intervention: stable isotope infusions (Other)
Sponsored by: Indiana University
Official(s) and/or principal investigator(s):
Steven J Steiner, MD, Principal Investigator, Affiliation: Indiana University
Steven J Steiner, MD, Phone: 317-274-3774
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.
Official title: Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
Study design: Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings.
Secondary outcome: Compare whole body protein metabolism in children with newly diagnosed Crohn's disease and ulcerative colitis before and 2 weeks after initiation of corticosteroid therapy.
Minimum age: 6 Years.
Maximum age: 18 Years.
- Male and female children between the ages of six and eighteen years of age
- Suspected inflammatory bowel disease or chronic abdominal pain not suspected of having
inflammatory bowel disease
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks
1. Hemoglobin >8. 0 g/dL
2. White blood cell count >3. 5 x 109/L
3. Neutrophils >1. 5 x 109/L
4. Platelets >100 x 109/L
5. Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase
levels within 3 times the upper limit of normal.
- Parent or guardian signing witnessed, informed consent
- Child (if > age 7) signing assent
- Known malignancy or history of malignancy within 5 years of enrollment.
- Positive stool examination for enteric pathogens including Salmonella and Shigella
species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- History of substance abuse.
- Poor tolerability of venipuncture or lack of venous access during the study period.
- Inability to comply with study procedures
Locations and Contacts
Steven J Steiner, MD, Phone: 317-274-3774
Indiana University - Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Starting date: January 2006
Ending date: January 2012
Last updated: December 21, 2007