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Protein and Energy Metabolism in Pediatric Crohn's Disease

6 Years
18 Years
Open (Enrolling)
Crohn's Disease, Protein Metabolism, Energy Metabolism

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Trial Information

Protein and Energy Metabolism in Pediatric Crohn's Disease

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Time Frame:

Week 0, 2 and 14

Safety Issue:


Principal Investigator

Steven J. Steiner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

January 2012

Related Keywords:

  • Crohn's Disease
  • Protein Metabolism
  • Energy Metabolism
  • Pediatric
  • Crohn's disease
  • protein metabolism
  • energy metabolism
  • Crohn Disease



Indiana University-Riley Hospital for Children Indianapolis, Indiana  46202