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临床试验/NCT02344758
NCT02344758已完成早期 1 期

Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine

University of Seville2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
134
试验地点
2
主要终点
Usual gluten-containing diet for healthy individuals

研究概览

简要总结

The purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.

详细描述

To date, the mainstay of the management of CD is a strict life-long adherence to gluten-free diet (GFD). Follow-up monitoring of the improvement of patients on GFD is essential to assess symptomatic recovery and to monitor complications, as well as to assist patients with dietary compliance. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.

In this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (GIP) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-GIP moAb immunochromatographic strips (IC-strips).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Celiac patient: childs (< 16 years) and adults (> 16 years)
  • written informed consent

排除标准

  • presence of family history of CD
  • digestive disease symptoms
  • known medical disease
  • use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study
  • 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

Usual gluten-containing diet for healthy individuals

时间窗: 1 month

次要结局

  • Usual gluten-free diet for celiac patients (home diet not modified for this trial)(1 month)

研究者

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

Carolina Sousa Martin

Professor

University of Seville

研究点 (2)

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