Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
IBD, CD, UC, Crohn's Disease, Ulcerative Colitis, Pediatric, inflammatory markers
Brief summary
The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4 beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease or from control patients. We hypothesize that the beta to alpha ratio will be higher in patients with active disease and that there will be a correlation between the ratio and the severity of disease.
Interventions
OTHERmeasurement of inflammatory markers
measuring inflammatory markers and comparing to controls.
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Children with a new diagnosis of Crohn's Disease and whose physician has not yet initiated corticosteroid treatment (10 Subjects): * Clinical diagnosis within the previous 21 days * Above age 7 and younger than age 18 * Signed informed consent statement and assent statement. * Children with a new diagnosis of Ulcerative Colitis and whose physician has not yet initiated corticosteroid treatment (10 Subjects): * Clinical diagnosis within the previous 21 days * Above age 7 and younger than age 18 * Signed informed consent statement and assent statement. * Children with Crohn's Disease whose physician has initiated Infliximab treatment for the first time (10 Subjects): * Clinical diagnosis of Crohn's Disease * Above age 7 and younger that age 18 * Signed informed consent statement and assent statement. * Children with Ulcerative Colitis whose physician has initiated Infliximab treatment for the first time (10 Subjects): * Clinical diagnosis of Ulcerative Colitis * Above age 7 and younger than age 18 * Signed informed consent statement and assent statement. * Healthy Controls (10 Subjects): * Above age 7 and younger than age 18 * otherwise healthy, with no intercurrent illness as determined by a member of the study team using the eligibility checklist * controls will be gender and age (± 2 years) matched to the patient groups described above * Signed informed consent statement and assent statement
Exclusion criteria
* unwilling to give consent for this study. * child with prior prescription and administration of Infliximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study hopes to assess the relative levels of the Stat4a and Stat4β isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, or from control patients. | Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D). |
Countries
United States
Outcome results
None listed