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临床试验/NCT02895438
NCT02895438已完成不适用

Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年5月27日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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