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

Indiana University

Status: Completed

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Other: measurement of inflammatory markers

Study type: Interventional

Funder types: Other

Identifiers

NCT00586599

IRB # 0707-69

0707-69

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

51 participants in 3 patient groups

Control

Other group

Description:

Subjects who have no inflammatory disease who will be age/gender matched controls for the 2 other arms.

Treatment:

Other: measurement of inflammatory markers

IBD and infliximab

Other group

Description:

Subjects who have IBD and will be receiving infliximab for the first time.

Treatment:

Other: measurement of inflammatory markers

Newly Diagnosed IBD

Other group

Description:

Subjects who are newly diagnosed with IBD and given corticosteroid therapy.

Treatment:

Other: measurement of inflammatory markers