Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
Primary Purpose
Crohn's Disease, Ulcerative Colitis, Protein Metabolism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stable isotope infusions
Sponsored by
About this trial
This is an interventional basic science trial for Crohn's Disease focused on measuring Pediatric, Crohn's disease, Ulcerative colitis
Eligibility Criteria
Inclusion Criteria:
- Male and female children between the ages of six and eighteen years of age
- Suspected inflammatory bowel disease or chronic abdominal pain not suspected of having inflammatory bowel disease
Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
- Hemoglobin >8.0 g/dL
- White blood cell count >3.5 x 109/L
- Neutrophils >1.5 x 109/L
- Platelets >100 x 109/L
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
- Parent or guardian signing witnessed, informed consent
- Child (if > age 7) signing assent
EXCLUSION CRITERIA:
- Known malignancy or history of malignancy within 5 years of enrollment.
- Positive stool examination for enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- History of substance abuse.
- Poor tolerability of venipuncture or lack of venous access during the study period.
- Inability to comply with study procedures
Sites / Locations
- Indiana University - Riley Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Normal
Newly diagnosed Crohn's disease
Newly diagnosed Ulcerative Colitis
Arm Description
Subjects who have normal endoscopic findings
Subjects who are newly diagnosed with Crohn's disease after endoscopy.
Subjects diagnosed with Ulcerative Colitis after endoscopy
Outcomes
Primary Outcome Measures
Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings.
Secondary Outcome Measures
Compare whole body protein metabolism in children with newly diagnosed Crohn's disease and ulcerative colitis before and 2 weeks after initiation of corticosteroid therapy.
Full Information
NCT ID
NCT00586352
First Posted
December 21, 2007
Last Updated
July 29, 2016
Sponsor
Indiana University
Collaborators
Indiana University Health
1. Study Identification
Unique Protocol Identification Number
NCT00586352
Brief Title
Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
Official Title
Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
Indiana University Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis, Protein Metabolism
Keywords
Pediatric, Crohn's disease, Ulcerative colitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal
Arm Type
Active Comparator
Arm Description
Subjects who have normal endoscopic findings
Arm Title
Newly diagnosed Crohn's disease
Arm Type
Active Comparator
Arm Description
Subjects who are newly diagnosed with Crohn's disease after endoscopy.
Arm Title
Newly diagnosed Ulcerative Colitis
Arm Type
Active Comparator
Arm Description
Subjects diagnosed with Ulcerative Colitis after endoscopy
Intervention Type
Other
Intervention Name(s)
stable isotope infusions
Intervention Description
Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
Primary Outcome Measure Information:
Title
Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings.
Time Frame
Week 0
Secondary Outcome Measure Information:
Title
Compare whole body protein metabolism in children with newly diagnosed Crohn's disease and ulcerative colitis before and 2 weeks after initiation of corticosteroid therapy.
Time Frame
Week 0 and Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female children between the ages of six and eighteen years of age
Suspected inflammatory bowel disease or chronic abdominal pain not suspected of having inflammatory bowel disease
Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
Hemoglobin >8.0 g/dL
White blood cell count >3.5 x 109/L
Neutrophils >1.5 x 109/L
Platelets >100 x 109/L
Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
Parent or guardian signing witnessed, informed consent
Child (if > age 7) signing assent
EXCLUSION CRITERIA:
Known malignancy or history of malignancy within 5 years of enrollment.
Positive stool examination for enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
Female subjects who are pregnant, nursing, or planning pregnancy.
History of substance abuse.
Poor tolerability of venipuncture or lack of venous access during the study period.
Inability to comply with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Steiner, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University - Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
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Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
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