Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Severity of IBS
研究概览
简要总结
Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is difficult, often resulting in a persistence of chronical abdominal pain.
In adults, many patients affected by IBS improve under a gluten-free diet, even in the absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the pathophysiological mechanisms also remain elusive.
The aim of this study is to determine if NCGS exists in children with IBS and to identify the clinical, serological, and histological characteristics, which could distinguish patients with NCGS from conventional IBS and CD patients.
This is a prospective cohort study in a population of children affected by a moderate to severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks. Then, children who improved under GFD were randomized in two groups for a double-blind placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with Irritable Bowel Syndrome (IBS)
排除标准
- •children with Celiac Disease (CD)
- •children with wheat allergy
研究组 & 干预措施
gluten
One group had a introduction of gluten followed by a wash-out period, then a placebo introduction, whereas the other group had the placebo first, then the wash-out and the gluten introduction.
干预措施: gluten (Dietary Supplement)
Placebo
One group had a introduction of gluten followed by a wash-out period, then a placebo introduction, whereas the other group had the placebo first, then the wash-out and the gluten introduction.
干预措施: gluten (Dietary Supplement)
结局指标
主要结局
Severity of IBS
时间窗: 12 weeks after randomisation
assessed though the composite score of FRANCIS
次要结局
- change in gastro-intestinal symptoms(12 weeks after randomisation)
- Change in quality of life(12 weeks after randomisation)
