Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586352
• Other study ID #: GCRC 1351
• Secondary ID: IRB 0512-16
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 29, 2016
• Start date: January 2006
• Est. completion date: November 2011

Study information

• Verified date: July 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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 of enrollment):

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

EXCLUSION CRITERIA:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Protein Metabolism
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• stable isotope infusions
Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.

Locations

Country	Name	City	State
United States	Indiana University - Riley Hospital for Children	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings.		Week 0	No
Secondary	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.		Week 0 and Week 2	No