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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586599
• Other study ID #: 0707-69
• Secondary ID: IRB # 0707-69
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: April 1, 2015
• Start date: August 2007
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• measurement of inflammatory markers
measuring inflammatory markers and comparing to controls.

Locations

Country	Name	City	State
United States	Indiana University-Riley Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study hopes to assess the relative levels of the Stat4a and Stat4ß isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, or from control patients.		Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).	No