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Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis - NCT00586599-46202(Clinical Trial 197193)



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City:  Indianapolis
State:  
IN
Zip Code: 46202
Conditions: Inflammatory Bowel Disease - Crohn's Disease - Ulcerative Colitis
Purpose: 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, 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.
Study summary:
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
Study is available at: Indiana University-Riley Hospital
Indianapolis, IN 46202
United States

Primary Contact:
Steven J Steiner, MD
Phone: 317-274-3774
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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