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



Status:Completed
Conditions:Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:7 - 17
Updated:3/30/2013
Start Date:August 2007
End Date:October 2012
Contact:Steven J Steiner, MD
Phone:317-274-3774

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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.


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
We found this trial at
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Indianapolis, Indiana 46202
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Indianapolis, IN
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