跳至主要内容
临床试验/NCT03663309
NCT03663309已完成不适用

Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten Immunogenic Peptides in Faecal Samples and Nutritional Assessment. Retrospective Study

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
1
主要终点
Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology.

研究概览

简要总结

To assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (GIP). This will provide an objective measure for adherence.

详细描述

The adherence to the GFD can be assessed through a dietary interview performed by a registered dietitian or patient self-reports, mucosal healing, assessed by a small bowel biopsy or CD serological screening tests showing decreasing levels of antibodies. However, none of these methods offer an accurate measure of dietary compliance. A novel method to monitor the adherence to the GFD by detection of immune-dominant gluten peptides in human faeces or urine using the anti-α -gliadin G12 antibody was described recently in the literature. Gluten peptides, in particular peptides equivalent to the immunogenic - α -gliadin-33-mer peptide, are resistant to gastrointestinal digestion and that ensures a significant amount of the ingested gluten is excreted in faeces. Consequently, recovery of detectable amounts of the immunogenic fraction in faeces or urine indicates that gluten has passed through the digestive tract, and in the case of urine was absorbed, and, therefore, that gluten has been consumed .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 2-17 years.
  • Either diagnosis of celiac disease or, in controls, no systemic disease or inflammation
  • For all groups parents will provide informed consent.

排除标准

  • ° Children with suspected or known inflammatory bowel disease or other gastrointestinal or systemic diseases.

结局指标

主要结局

Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology.

时间窗: one year

Our goal is to examine which method will be the most accurate, nutritional assessment or laboratory tests for the adherence to GFD

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

raanan shamir

Professor

Rabin Medical Center

研究点 (1)

Loading locations...

相似试验