Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Monitoring of gluten-free diet compliance in celiac patients
研究概览
简要总结
The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.
详细描述
Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.
This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Celiac patient
- •1-12 years old
- •Written informed consent
排除标准
- •Known inflammatory bowel diseases
- •Participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
结局指标
主要结局
Monitoring of gluten-free diet compliance in celiac patients
时间窗: April-July 2011 (3 months)
Usual gluten diet for celiac (home diet not modified for this trial)
次要结局
未报告次要终点
研究者
Carolina Sousa Martin
Principal Investigator
University of Seville