Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

NCT ID: NCT00586807

Last Updated: 2009-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2008-09-30

Brief Summary

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

Conditions

Ulcerative Colitis; Protein Metabolism; Energy Expenditure

Keywords

Ulcerative colitis; pediatrics; UC; protein metabolism; energy expenditure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Infliximab

Subjects on infliximab

Group Type: OTHER

Stable amino acid isotopes

Intervention Type: OTHER

Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.

Interventions

Stable amino acid isotopes

Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASPEN Rhoads Research Foundation

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Indiana University

Principal Investigators

Steven J Steiner, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University- Riley Hospital for Children

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IRB #0503-23

Identifier Type: -

Identifier Source: secondary_id

GCRC 1274

Identifier Type: -

Identifier Source: org_study_id