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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00586599
First received: December 21, 2007
Last updated: April 8, 2013
Last verified: April 2013
  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, 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.


Condition Intervention
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Other: measurement of inflammatory markers

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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. [ Time Frame: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D). ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Subjects who have no inflammatory disease who will be age/gender matched controls for the 2 other arms.
Other: measurement of inflammatory markers
measuring inflammatory markers and comparing to controls.
IBD and infliximab
Subjects who have IBD and will be receiving infliximab for the first time.
Other: measurement of inflammatory markers
measuring inflammatory markers and comparing to controls.
Newly Diagnosed IBD
Subjects who are newly diagnosed with IBD and given corticosteroid therapy.
Other: measurement of inflammatory markers
measuring inflammatory markers and comparing to controls.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586599

Locations
United States, Indiana
Indiana University-Riley Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Steven J Steiner, MD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00586599     History of Changes
Other Study ID Numbers: 0707-69, IRB # 0707-69
Study First Received: December 21, 2007
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
IBD
CD
UC
Crohn's Disease
Ulcerative Colitis
Pediatric
inflammatory markers

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014