I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- I-FABP levels during remission
研究概览
简要总结
A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.
详细描述
I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.
排除标准
- •Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
- •Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
- •NSAID use in the last week.
- •Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
- •Known genetic disorders (such as Down's syndrome).
- •Patients whose TTG was elevated but lower than 3 times the normal range.
结局指标
主要结局
I-FABP levels during remission
时间窗: 6 months & 12 months after enrollment
Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)
I-FABP levels at diagnosis
时间窗: 1 day of enrollment
Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
次要结局
未报告次要终点
研究者
Dr. Assaf Hoofien
Research fellow
Schneider Children's Medical Center, Israel