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Protein and Energy Metabolism in Pediatric Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00583232
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : March 16, 2017
Sponsor:
Collaborators:
GlaxoSmithKline
Crohn's and Colitis Foundation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Indiana University

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 31, 2007
Last Update Posted Date March 16, 2017
Study Start Date  ICMJE February 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Compare whole body and splanchnic protein kinetics and balance in response to corticosteroid and anti-TNF-alpha therapies in the fasting state and during enteral nutrition infusion. [ Time Frame: Week 0, 2 and 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on resting and total energy expenditure. [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on free fatty acid metabolism [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on quality of life [ Time Frame: Week 0, 2, and 14 ]
  • Comparing the effects of corticosteroid and anti-TNF-alpha therapies on bone turnover and bone density [ Time Frame: Week 0,2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on body composition. [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on cytokines known to be altered in inflammatory bowel disease. [ Time Frame: Week 0, 2 and 14 ]
  • Compare the effects of corticosteroid and anti-TNF-alpha therapies on vascular endothelial function. [ Time Frame: Week 0, 2 and 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein and Energy Metabolism in Pediatric Crohn's Disease
Official Title  ICMJE Protein and Energy Metabolism in Pediatric Crohn's Disease
Brief Summary

The metabolic response to Crohn's disease, 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 compare changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this study will better define the changes in nutrition status observed in these children following remission of active Crohn's disease, and potentially lead to changes in medical and nutritional management of these children.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Crohn's Disease
  • Protein Metabolism
  • Energy Metabolism
Intervention  ICMJE Drug: Stable isotope infusions
Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
Study Arms  ICMJE
  • Active Comparator: Corticosteroid
    Subjects receiving corticosteroid therapy (1-2 mg/kg/day up to 60mg/day) with taper.
    Intervention: Drug: Stable isotope infusions
  • Active Comparator: infliximab
    Subjects receiving infliximab therapy (5 mg/kg at 0, 2 and 6 weeks, followed by every 8 week therapy)
    Intervention: Drug: Stable isotope infusions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
34
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female children between the ages of six and eighteen years of age with recurrence of active Crohn's disease, determined by their primary pediatric gastroenterologist to require either:

    1. Corticosteroid therapy ((1-2 mg/kg/d up to maximum of 60 mg/day) with taper, or
    2. Infliximab therapy (5 mg/kg at 0, 2, and 6 weeks, followed by q 8 week therapy)
  • Crohn's disease of at least 3 months since diagnosis, with gastritis, duodenitis, ileitis, ileocolitis, or colitis, confirmed by endoscopy and biopsy
  • PCDAI score >20
  • If receiving concomitant medications, must have been on a stable regimen as follows:

    1. Subjects on aminosalicylates and/or immunomodulators should be on a stable dose for at least 2 weeks prior to enrollment.
    2. Subjects must be off oral, rectal, and parenteral corticosteroids at least 2 weeks prior to enrollment.
  • 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.
  • For those patients to receive infliximab, PPD skin tests 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:

  • Local manifestations of Crohn's disease, including fistula(s), strictures, abscesses, or other complications for which surgery may be indicated.
  • Surgery for bowel diversion with placement of stoma within 3 months prior to screening.
  • Positive stool examination of enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
  • Female subjects who are pregnant, nursing, or planning pregnancy.
  • Concomitant diagnosis or history of congestive heart failure.
  • Treatment with parenteral nutrition within 4 weeks of enrollment.
  • 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.
  • 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-a (TNF-a).
  • Hypersensitivity to any murine proteins or other component of infliximab for those patients to receive infliximab.
  • Inability to comply with study procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583232
Other Study ID Numbers  ICMJE 0506-19
IRB 0506-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE
  • GlaxoSmithKline
  • Crohn's and Colitis Foundation
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Steven J. Steiner, MD Indiana University
PRS Account Indiana University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP