Expired Study
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Indianapolis, Indiana 46202


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


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


Study is Available At:


Original ID:

GCRC 1274


NCT ID:

NCT00586807


Secondary ID:

IRB #0503-23


Study Acronym:


Brief Title:

Metabolic Response to Infliximab in Pediatric Ulcerative Colitis


Official Title:

Metabolic Response to Infliximab in Pediatric Ulcerative Colitis


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

6 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

poor enrollment


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Steven J Steiner, MD
Principal Investigator
Indiana University

Study Dates

Start Date:June 2005
Completion Date:September 2008
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:January 2009
Last Changed Date:January 29, 2009
First Received Date:December 21, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Stable amino acid isotopes
Description:Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.
Arm Name:Infliximab

Study Arms

Study Arm Type:Other
Arm Name:Infliximab
Description:Subjects on infliximab

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:ASPEN Rhoads Research Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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