Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 14
- 主要终点
- Clinical safety through serological markers of coeliac disease and intestinal wall integrity, clinical and bioumoral parameters of nutrition status, frequency and clinical type of dyspeptic disorders or other adverse reactions.
研究概览
简要总结
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.
详细描述
Several clinical trials have demonstrated that most celiac patients, both of pediatric and of adult age, can take medium-high quantity of oat (50-100 g/day), without any negative clinical effects.
In a small number of cases intestinal dyspeptic disorders, especially meteorism, can be observed, particularly during the first weeks of oat intake. They are generally without clinical significance because they are a consequence of the increased fibre intake.
There are only few cases of "true" oats intolerance. The addition of oat improves the nutritional quality of the gluten-free diet, particularly due to the increased intake of fibre and some oligoelements (iron, zinc, tiamin, pholates) and expands the spectrum of food choices.
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.
For the oat-based product to be considered suitable in the dieto-therapy of coeliac disease, the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the study will include patients aged between 4 and 14, under treatment with a gluten-free diet for coeliac disease (bioptic diagnosis) for at least two years.
排除标准
- •diagnosis not confirmed by intestinal biopsy, cases with little adherence to the treatment (anti-tTG positive at basal evaluation), cases of potential coeliac disease (completely normal mucous membrane), cases with an associated sieric IgA deficit, cases with associated diseases (es. diabetes type 1).
研究组 & 干预措施
A/B
This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
干预措施: Gluten-free products (Other)
结局指标
主要结局
Clinical safety through serological markers of coeliac disease and intestinal wall integrity, clinical and bioumoral parameters of nutrition status, frequency and clinical type of dyspeptic disorders or other adverse reactions.
时间窗: Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.
次要结局
- Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.(Product liking questionnaire after 6 months and 15 months from the beginning of the study.)