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NCT00586352 · ClinicalTrials.gov registry record · NA
Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
A NA study of Ulcerative Colitis and Crohn's Disease, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00586352 is a NA study of Ulcerative Colitis and Crohn's Disease that has completed, run by Indiana University. The registered enrollment target is 31 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00586352, a NA study of Ulcerative Colitis and Crohn's Disease, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in the colon. Children with inflammatory bowel disease frequently suffer from disturbances in growth, which may continue into adulthood and result in altered growth outcomes. The metabolic response to inflammatory bowel disease, including increased protein breakdown and decreased protein synthesis may play a significant role in the resulting malnutrition and growth failure from which children with inflammatory bowel disease suffer. The purpose of this study is to compare the rates of protein synthesis within the mucosal lining of the gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have normal endoscopic examinations. By comparing children with inflammatory bowel disease to normal children, we can begin to determine how alterations in protein metabolism within the lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a follow-up study will be conducted two weeks following the initiation of steroid therapy to determine its effects on protein metabolism. We hypothesize that children with active inflammatory bowel disease will have increased rates of protein synthesis in the lining of the gastrointestinal tract than patients who have normal endoscopy, and that increases in protein breakdown and protein synthesis will be improved following steroid therapy in children with newly diagnosed inflammatory bowel disease.
Conditions Studied
Interventions
- OTHER stable isotope infusions
Study Locations (1)
Indiana
- Indiana University - Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00586352
The ClinicalTrials.gov registry entry for NCT00586352 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which stable isotope infusions is the first listed.
NCT00586352 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT00586352 about?
NCT00586352 is a clinical study titled "Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease". Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any part of the gastrointestin...
What is the current status of trial NCT00586352?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2006-01. Estimated completion is 2011-11.
What conditions does trial NCT00586352 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease, Protein Metabolism.
What interventions are being tested in trial NCT00586352?
The interventions under investigation include: stable isotope infusions (OTHER).
Who is sponsoring clinical trial NCT00586352?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00586352 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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