Inflammatory Bowel Disease (IBD)
Conditions
Keywords
Inflammatory Bowel Disease (IBD)
Brief summary
The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.
Interventions
DRUGDexamethasone
DRUGMethylprednisolone
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Parental informed consent * Subjects 6 to 19 years of age with confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis), who on admission to the hospital have a PCDAI\>15 or a Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis of \>10. * Infectious causes (viruses, bacteria, parasites) have been ruled out.
Exclusion criteria
* Subjects in which the administration of corticosteroids would be contraindicated such as systemic or enteric infections diagnosed by stool analysis including culture, Clostridium Difficile toxin assay, rotavirus or adenovirus 40/41 antigens. * Subjects with enterostomy or colostomy * Subjects with one or more of the following conditions: unstable vital signs, acute abdomen, toxic megacolon, intestinal obstruction, intestinal perforation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pediatric Crohn's Disease Activity Index (PCDAI) | — |
| Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Harvey Bradshaw score (pHB) | — |
Countries
United States
Outcome results
None listed