Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine
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
- 否
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
Carolina Sousa Martin
Professor
University of Seville