Back to resultsMetabolic Response to Infliximab in Pediatric Ulcerative Colitis
Primary Purpose
Ulcerative Colitis, Protein Metabolism, Energy Expenditure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stable amino acid isotopes
Sponsored by
About this trial
This is an interventional basic science trial for Ulcerative Colitis focused on measuring Ulcerative colitis, pediatrics, UC, protein metabolism, energy expenditure
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):
- Hemoglobin >8.0 g/dL
- White blood cell count >3.5 x 109/L
- Neutrophils >1.5 x 109/L
- Platelets >100 x 109/L
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
- PPD skin test with skin induration <5 mm.
- 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
Sites / Locations
- Indiana University- Riley Hospital for Children
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Infliximab
Arm Description
Subjects on infliximab
Outcomes
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.
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.
Full Information
NCT ID
NCT00586807
First Posted
December 21, 2007
Last Updated
January 29, 2009
Sponsor
Indiana University
Collaborators
ASPEN Rhoads Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00586807
Brief Title
Metabolic Response to Infliximab in Pediatric Ulcerative Colitis
Official Title
Metabolic Response to Infliximab in Pediatric Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
poor enrollment
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University
Collaborators
ASPEN Rhoads Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Protein Metabolism, Energy Expenditure
Keywords
Ulcerative colitis, pediatrics, UC, protein metabolism, energy expenditure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infliximab
Arm Type
Other
Arm Description
Subjects on infliximab
Intervention Type
Other
Intervention Name(s)
Stable amino acid isotopes
Intervention Description
Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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):
Hemoglobin >8.0 g/dL
White blood cell count >3.5 x 109/L
Neutrophils >1.5 x 109/L
Platelets >100 x 109/L
Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
PPD skin test with skin induration <5 mm.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Steiner, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University- Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
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Metabolic Response to Infliximab in Pediatric Ulcerative Colitis
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