Study of the Use of a Home Test for the Detection of Gluten Immunogenic Peptides in Urine and Its Effect on Gluten-free Diet Adherence
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Gluten-free adherence change
研究概览
简要总结
The use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement.
This single centre, randomized, unblinded, controlled study consists of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention group (home urine GIP testing) or the control group (no home urine GIP testing). The 12-week study will involve surveys, home stool and urine collection, home urine GIP test performance, and two study visits with the gastroenterologists.
The main outcome is to determine whether the self-monitoring of the GFD with GIP testing in urine improves adherence to the GFD in treated adolescent patients with CD (measured by CDAT-Celiac Dietary Adherence Test, GFD adherence evaluation by gastroenterologist and rates of gluten exposure in urine and/or stool measured at a central laboratory) and subsequently improves quality of life (CDDUX-Coeliac Disease Dutch Questionnaire) and reduces symptoms (CSI-Celiac Symptoms Index questionnaire).
详细描述
Hypothesis: the use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement.
Objectives:
Primary objective: to determine in adolescent patients with CD whether the self-monitoring of the GFD with GIP testing in urine changes treatment adherence (intervention group) in comparison with patients that do not use the test (control group) measured by 1 - CDAT-Celiac Dietary Adherence Test; 2 - GFD adherence evaluation by gastroenterologist; 3- Detection rates of GIP in urine and/or stool (to be measured at a central laboratory); 4- Detection rates of GIP in urine (to be measured by home rapid tests).
Secondary objectives: to determine whether the use of the home test for GIP detection in urine samples of treated patients with CD leads to 1 - change of quality of life (CDDUX-Coeliac Disease Dutch Questionnaire); 2- change of symptoms (CSI-Celiac Symptoms Index questionnaire).
Study design: Single centre, randomized, unblinded, controlled, study. The study will consist of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention (home urine GIP testing) or the control group (no home urine GIP testing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to take part in the study.
- •Signed informed consent.
- •Diagnosis of CD confirmed by biopsy and/or serology.
- •Ability to: provide urine and stool samples, perform the home tests, and register results.
排除标准
- •Not precise diagnostic of CD.
- •Comorbid condition that in the opinion of the investigator would interfere with the study.
- •Lack of willingness to take part in the study.
- •Inability to use the test or provide samples.
- •Frequent voluntary GFD transgressions.
- •To provide less than 70% of the required samples.
研究组 & 干预措施
GlutenDetect home urine test
The GlutenDetect home urine test group will receive home use tests for GIP detection in urine to self-monitor the GFD. Tests will be used at their discretion, but using at least 8 tests during the study period (1/week), so that they may receive immediate qualitative feedback regarding the presence of biomarkers of gluten exposure in their urine and they will have to register the results obtained. Additionally, patients will collect a urine and a stool sample every 4 weeks to evaluate their adherence to the GFD in the laboratory.
干预措施: GlutenDetect home urine test (Diagnostic Test)
Control group
The control group will not receive any home urine tests but will collect a urine and a stool sample every 4 weeks with the purpose of evaluating their adherence to the GFD in the laboratory.
结局指标
主要结局
Gluten-free adherence change
时间窗: 8 weeks
Number of participants adherent to GFD in intervention and control arms as assessed by Celiac Dietary Adherence Test (CDAT), change from baseline in scores on the test after 8 weeks of intervention. The scores on the CDAT have a scale from 7 to 35. A score of \<13 is considered as good diet adherence and a score \>17 is considered as bad diet adherence.
次要结局
- Quality of life change(8 weeks)
- Symptoms change(8 weeks)