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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type OTHER

measurement of inflammatory markers

Intervention Type OTHER

measuring inflammatory markers and comparing to controls.

IBD and infliximab

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

Group Type OTHER

measurement of inflammatory markers

Intervention Type OTHER

measuring inflammatory markers and comparing to controls.

Newly Diagnosed IBD

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

Group Type OTHER

measurement of inflammatory markers

Intervention Type OTHER

measuring inflammatory markers and comparing to controls.

Interventions

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measurement of inflammatory markers

measuring inflammatory markers and comparing to controls.

Intervention Type OTHER

Eligibility Criteria

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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