Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

January 29, 2009 updated by: Indiana University

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 0 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 0 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

ASPEN Rhoads Research Foundation

Investigators

  • Principal Investigator: Steven J Steiner, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

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)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCRC 1274
  • IRB #0503-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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