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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 0506-19 |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Crohn's and Colitis Foundation | OTHER |
| National Center for Research Resources (NCRR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid | Active Comparator | Subjects receiving corticosteroid therapy (1-2 mg/kg/day up to 60mg/day) with taper. |
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| infliximab | Active Comparator | Subjects receiving infliximab therapy (5 mg/kg at 0, 2 and 6 weeks, followed by every 8 week therapy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stable isotope infusions | Drug | Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, 2 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of corticosteroid and anti-TNF-alpha therapies on resting and total energy expenditure. | Week 0, 2 and 14 | |
| Compare the effects of corticosteroid and anti-TNF-alpha therapies on free fatty acid metabolism | Week 0, 2 and 14 |
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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:
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:
Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
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:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J. Steiner, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University-Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Compare the effects of corticosteroid and anti-TNF-alpha therapies on quality of life | Week 0, 2, and 14 |
| Comparing the effects of corticosteroid and anti-TNF-alpha therapies on bone turnover and bone density | Week 0,2 and 14 |
| Compare the effects of corticosteroid and anti-TNF-alpha therapies on body composition. | 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. | Week 0, 2 and 14 |
| Compare the effects of corticosteroid and anti-TNF-alpha therapies on vascular endothelial function. | Week 0, 2 and 14 |
| D007410 | Intestinal Diseases |