Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

This study has been terminated.
(poor enrollment)
Sponsor:
Collaborator:
ASPEN Rhoads Research Foundation
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00586807
First received: December 21, 2007
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has been incriminated in the mechanism of weight loss in many different chronic diseases, and causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven to be an effective therapy for ulcerative colitis.

The purpose of this study is to determine changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) in children with ulcerative colitis. Performing this study will better define the changes in nutrition status observed in these children following remission of active ulcerative colitis, and potentially lead to changes in medical and nutritional management of these children


Condition Intervention
Ulcerative Colitis
Protein Metabolism
Energy Expenditure
Other: Stable amino acid isotopes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Measure protein kinetics and balance in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion. [ Time Frame: Week 0 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. Measure energy expenditure by indirect calorimetry in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion. [ Time Frame: Week 0 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Infliximab
Subjects on infliximab
Other: Stable amino acid isotopes
Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.

  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
  • Endoscopic or histologic evidence of ulcerative colitis
  • Active ulcerative colitis determined by primary pediatric gastroenterologist to require anti-tumor necrosis factor-alpha antibody (infliximab) therapy
  • Colitis symptom score ≥2
  • 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.
    6. PPD skin test with skin induration <5 mm.
    7. Signed written consent from the parent/legal guardian and assent from the child to be obtained prior to enrollment.

Exclusion Criteria:

  • Female subjects who are pregnant, nursing, or planning pregnancy.
  • Concomitant diagnosis or history of congestive heart failure.
  • Serious infection in the 3 months prior to enrollment.
  • History of prior or current active or latent tuberculosis.
  • Immune deficiency syndrome, including documented human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  • History of systemic lupus erythematosus.
  • A transplanted organ.
  • Known malignancy or history of malignancy within 5 years of enrollment.
  • History of demyelinating disease.
  • History of substance abuse.
  • History of diabetes mellitus.
  • Poor tolerability of venipuncture or lack of venous access during the study period.
  • A live virus vaccination within 3 months of enrollment.
  • Prior history of infliximab infusion or any other therapeutic agent targeted at reducing tumor necrosis factor-alpha (TNF-alpha).
  • Hypersensitivity to any murine proteins or other component of the product.
  • Inability to comply with study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586807

Locations
United States, Indiana
Indiana University- Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
ASPEN Rhoads Research Foundation
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: NCT00586807     History of Changes
Other Study ID Numbers: GCRC 1274, IRB #0503-23
Study First Received: December 21, 2007
Last Updated: January 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Ulcerative colitis
pediatrics
UC
protein metabolism
energy expenditure

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014