Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Indiana University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Clarian Health Partners
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00586352
First received: December 21, 2007
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Crohn's Disease
Ulcerative Colitis
Protein Metabolism
Other: stable isotope infusions

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Week 0 and Week 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2006
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586352

Locations
United States, Indiana
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Clarian Health Partners
Investigators
Principal Investigator: Steven J Steiner, MD Indiana University
  More Information

No publications provided

Responsible Party: Steven J. Steiner, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00586352     History of Changes
Other Study ID Numbers: GCRC 1351, IRB 0512-16
Study First Received: December 21, 2007
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Pediatric
Crohn's disease
Ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014