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

NCT00586599 | Completed

• 2 other identifiers: 0707-69IRB # 0707-69
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

IBD; CD; UC; Crohn's Disease; Ulcerative Colitis; Pediatric; inflammatory markers

Outcome Measures

Primary Outcomes (1)

• This study hopes to assess the relative levels of the Stat4a and Stat4β 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).

Study Arms (3)

Control

OTHER

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

Other: measurement of inflammatory markers

IBD and infliximab

OTHER

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

Other: measurement of inflammatory markers

Newly Diagnosed IBD

OTHER

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

Other: measurement of inflammatory markers

Interventions

measurement of inflammatory markers OTHER

measuring inflammatory markers and comparing to controls.

Control; IBD and infliximab; Newly Diagnosed IBD

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• unwilling to give consent for this study.
• child with prior prescription and administration of Infliximab

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University-Riley Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Steven J Steiner, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: August 1, 2007
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

US (1)