Clinical trial NCT00586599: Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
Official title: Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: IBD
CD
UC
Crohn's Disease
Ulcerative Colitis
Pediatric
inflammatory markers
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 51
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


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

Primary outcomes:
measure: 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.
timeFrame: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University-Riley Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Steven J Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References: