Interest of Urinary Measurement of Immunogenic Gluten Peptides (GIP) in the Follow-up of Pediatric Celiac Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The main reason for insufficient control of celiac disease is non-adherence to the gluten-free diet (GFD), whether voluntary or involuntary. In children, involuntary exposures are common (canteens, snacks, restaurants). There are no evidence-based recommendations regarding the best way to follow up with patients and assess adherence to the diet. Monitoring of celiac disease is traditionally based on IgA anti-transglutaminase (IgA anti-tTG) serology, but it reflects a delayed immune response and does not detect occasional exposures. Numerous studies conducted outside of France seem to highlight the usefulness of measuring gluten immunogenic peptides (GIP), compared to the current tools used. Measuring GIP in urine, which is non-invasive and can be performed regularly, could allow for earlier and more objective detection of recent gluten exposure, particularly inadvertent exposure, even before symptoms appear. Furthermore, it could serve as a complementary test for patients who continue to show symptoms or positive serology despite a reported well-followed GFD. In such situations, the use of control esophagogastroduodenoscopy (EGD) with jejunal biopsies could be reconsidered in the event of positive urinary GIP. This is the first study conducted in France on the usefulness of urinary measurement of immunogenic gluten peptides in the follow-up of pediatric celiac patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 to 18 years.
- •Confirmed diagnosis of celiac disease according to ESPGHAN criteria.
- •Gluten-free diet followed for ≥ 6 months.
- •Signed informed consent by one of the 2 parents or the legal guardian and oral or written assent from the child.
- •Affiliation to a social security scheme
排除标准
- •Predictable compliance problem in the study
- •Non-French-speaking patient
- •Seronegative celiac disease at diagnosis
- •Chronic kidney disease
- •Patient protected by law, that is, subject to protective measures (judicial safeguard, guardianship, trusteeship, procedures for opening guardianship and trusteeship measures)
研究者
Aline JOULIE
Clinical trial manager
Fondation Lenval
