Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •unwilling to give consent for this study.
- •child with prior prescription and administration of Infliximab
研究组 & 干预措施
Control
Subjects who have no inflammatory disease who will be age/gender matched controls for the 2 other arms.
干预措施: measurement of inflammatory markers (Other)
IBD and infliximab
Subjects who have IBD and will be receiving infliximab for the first time.
干预措施: measurement of inflammatory markers (Other)
Newly Diagnosed IBD
Subjects who are newly diagnosed with IBD and given corticosteroid therapy.
干预措施: measurement of inflammatory markers (Other)
结局指标
主要结局
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.
时间窗: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).
次要结局
未报告次要终点