Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis

Study Overview
=================
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.

Official Title
-----------------
Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: measurement of inflammatory markers


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Subjects who have no inflammatory disease who will be age/gender matched controls for the 2 other arms. | Other: measurement of inflammatory markers<br>* measuring inflammatory markers and comparing to controls.<br>|
| Other: IBD and infliximab<br>Subjects who have IBD and will be receiving infliximab for the first time. | Other: measurement of inflammatory markers<br>* measuring inflammatory markers and comparing to controls.<br>|
| Other: Newly Diagnosed IBD<br>Subjects who are newly diagnosed with IBD and given corticosteroid therapy. | Other: measurement of inflammatory markers<br>* measuring inflammatory markers and comparing to controls.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, CD, UC, Crohn's Disease, Ulcerative Colitis, Pediatric, inflammatory markers