Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis; Protein Metabolism
• Intervention / Treatment: Other: stable isotope infusions

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University - Riley Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal; Subjects who have normal endoscopic findings	Other: stable isotope infusions; Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
Active Comparator: Newly diagnosed Crohn's disease; Subjects who are newly diagnosed with Crohn's disease after endoscopy.	Other: stable isotope infusions; Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
Active Comparator: Newly diagnosed Ulcerative Colitis; Subjects diagnosed with Ulcerative Colitis after endoscopy	Other: stable isotope infusions; Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health
• Investigators: Principal Investigator: Steven J Steiner, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 4, 2008

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Pediatric; Crohn's disease; Ulcerative colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: GCRC 1351; IRB 0512-16 (Other Identifier: Indiana University)