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OpenTrials
Completed

NCT Number: NCT00586599

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

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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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University-Riley Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

measurement of inflammatory markers

Other

measuring inflammatory markers and comparing to controls.

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.

    Time frame: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2008
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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