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临床试验/NCT03771443
NCT03771443已完成3 期

Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月21日最近更新:
适应症
干预措施
相关药物

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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Adel Abd Elhameed

master degree student

Cairo University

研究点 (1)

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