Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB 0512-16 | Other Identifier | Indiana University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indiana University Health | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Active Comparator | Subjects who have normal endoscopic findings |
|
| Newly diagnosed Crohn's disease | Active Comparator | Subjects who are newly diagnosed with Crohn's disease after endoscopy. |
|
| Newly diagnosed Ulcerative Colitis | Active Comparator | Subjects diagnosed with Ulcerative Colitis after endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stable isotope infusions | Other | Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings. | Week 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 and Week 2 |
Not provided
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):
Parent or guardian signing witnessed, informed consent
Child (if > age 7) signing assent
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |