The Pediatric Inflammatory Bowel Disease Registry (IRB# 33317)
- Principal Investigator: Marc E. Schaefer, MD, MPH
The two primary goals for this study are (1) to describe contemporary trends in disease expression and management and relate them to emerging information on the laboratory characteristics of these diseases, (2) prospectively assess the efficacy, safety and tolerability of currently prescribed or newly emerging therapies including infliximab in the pediatric IBD population.
1. Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
2. Age up to 16 years and zero days at time of diagnosis
3. Informed consent/assent from parent/guardian and patient
4. Ability to be available for regular follow-up visits
1. Diagnosis of IBD greater than 1 month prior to presentation to participating center
2. Age greater than 16 years and zero days
3. Inability to be available for regular follow-up visits
Additional Study Details:
What is expected of me and my child?
1. At the time of diagnosis a detailed data form will be completed by the physician recording the clinical and laboratory characteristics of the participating child's illness.
2. Subsequent data forms will also be completed 30 days following the diagnosis and then every 3 months for up to 7 years after that. These data forms will contain information on therapies that are used in the treatment of the participating child's illness.
3. At the time of diagnosis and every 3 months the participating child will be asked to complete a questionnaire (10 minutes to complete) on the quality of their life.
4.This study will not affect the participating child's care in anyway, nor will the child have any testing that would not ordinarily have been done. Visits will be scheduled in the customary fashion.
5. There is a one-time optional blood draw to study the proteins and genes that may be related to IBD.
Pediatric Clinical Research Office