Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ulcerative events
研究概览
简要总结
Celiac disease (CD) is the most common genetically based food intolerance in the world, with a prevalence among approximately 1% of the general population (Guandalini & Assiri, 2014). CD is a frequent disorder among Egyptian children, both in the general population and in at-risk groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong adherence to a strict gluten free diet (GFD) remains the only available treatment for patients with CD and typically results in a complete return to health. Nevertheless, gluten is not found only in diet, Gluten is commonly used as a binder in products like medication, cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes and other oral health products and it can be swallowed by mistake and initiate immune response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste in Egypt has become mandatory.
详细描述
production of an experimental gluten free toothpaste and providing it for children with celiac disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 6 yeas.
- •Erupting lower
- •Can spit the toothpaste.
- •Diagnosed as a celiac patient(pathology&serology)
排除标准
- •With a history of allergy to any ingredient present in the toothpaste to be used for treatment
- •The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- •Children whose parents had no home or mobile phone to enable post-operative contact.
- •Parent that will not sign the consent.
研究组 & 干预措施
gluten free toothpaste
experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months
干预措施: experimental gluten free toothpaste (Drug)
结局指标
主要结局
Ulcerative events
时间窗: Six months
Reporting from the parent (Yes or No)
次要结局
- Inflammation or ulceration(six months)
研究者
Eman Adel Abd Elhameed
master degree student
Cairo University
