Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus
Evaluation of Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus at Assiut University Children Hospital
This cross-sectional case-control study aims to evaluate fecal calprotectin levels and intestinal ultrasound findings for the detection of subclinical gastrointestinal involvement in children with juvenile systemic lupus erythematosus compared with healthy controls.
研究概览
详细说明
Juvenile systemic lupus erythematosus is a chronic multisystem autoimmune disease. Gastrointestinal involvement may be under-recognized and can be subclinical.
This observational study will measure fecal calprotectin and perform intestinal ultrasound in children with JSLE and age- and sex-matched healthy controls to assess subclinical gastrointestinal involvement.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Manar k M, Resident
- 电话号码：+20 11 49443518
- 邮箱：mnark024@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Children with juvenile systemic lupus erythematosus and age- and sex-matched healthy controls attending Assiut University Children Hospital.
描述
Inclusion Criteria:
- Children less than 18 years of age
- Diagnosis of juvenile systemic lupus erythematosus according to SLICC criteria
- Disease duration of at least 3 months
- Age- and sex-matched healthy controls
- Written informed consent from parents or legal guardians
Exclusion Criteria:
- - Established diagnosis of inflammatory bowel disease or other primary gastrointestinal disorder
- Significant gastrointestinal manifestations (persistent abdominal pain, diarrhea, vomiting, GI bleeding, significant unexplained weight loss)
- Active gastrointestinal infection within the preceding 4 weeks
- Antibiotics, probiotics, or NSAIDs within the 2 weeks preceding stool sample collection
- Other autoinflammatory or overlapping autoimmune diseases
- Chronic liver or renal disease unrelated to JSLE
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：CROSS_SECTIONAL
队列和干预
团体/队列 |
|---|
|
Juvenile Systemic Lupus Erythematosus
Children with JSLE according to SLICC criteria with disease duration of at least 3 months. |
|
Healthy Controls
Age- and sex-matched healthy children. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean fecal calprotectin level
大体时间：Baseline
|
Mean fecal calprotectin concentration measured by ELISA in µg/g. |
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of children with elevated fecal calprotectin
大体时间：Baseline
|
Proportion of children with fecal calprotectin level above the laboratory reference range. |
Baseline
|
|
Proportion of children with abnormal intestinal ultrasound findings
大体时间：Baseline
|
Proportion of children showing bowel-wall thickening or increased vascularity on intestinal ultrasound. |
Baseline
|
|
Mean SLEDAI-2K score
大体时间：Baseline
|
Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. |
Baseline
|
|
Mean bowel wall thickness on ultrasound
大体时间：Baseline
|
Mean bowel wall thickness in millimeters measured by intestinal ultrasound. |
Baseline
|
合作者和调查者
调查人员
- 学习椅：Mostafa s Khalaf, prof、Pediatrics Department, Assiut University Hospitals
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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