Study of the Prevalence of Gluten-dependent Diseases in the Russian Population and the Development of New Biotechnological Approaches to Obtain Gluten-free Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,070
- 试验地点
- 1
- 主要终点
- Serological and genetic studies at risk group
研究概览
简要总结
To study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies.
详细描述
The purpose of this screening program is to identify people at high risk for developing celiac disease, which is due to the genetic intolerance of gluten - a protein found in wheat, rye and barley. When a person with celiac disease consumes gluten-containing foods, his immune system damages the mucous membrane of the small intestine. Inflammation develops and, as a result, the absorption of vitamins, minerals and other vital nutrients is disrupted. Studies have shown that timely diagnosis of celiac disease is important for the treatment or prevention of its complications. Left untreated, the disease can lead to impaired growth and development, diabetes, cancer, or other diseases. In Europe and the USA, celiac disease is a chronic disease that occurs in approximately one in 100 and one in 22 who have risk factors. There are frequent cases of an erased or low-symptom course of celiac disease. Unfortunately, ninety-seven percent of cases remain undiagnosed and, accordingly, do not receive proper treatment. A screening program will increase knowledge about the disease and contribute to the early detection of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schoolchildren from various districts of Moscow selected as a result of questioning in the risk group for the development of celiac disease
- •Availability of written informed consent of the child over 14 years of age to participate in the study;
- •Availability of written informed consent of the parent of the child to participate in the study;
- •Age from 7 to 18 years;
- •Male and female gender;
- •The number of points according to the results of the survey is more than 25.
排除标准
- •Age up to 7 years and over 18 years.
- •The lack of written informed consent of the child over 14 years of age to participate in the study;
- •The lack of written informed consent of the parent / guardian of the child to participate in the study;
- •The number of points on the results of the survey from 0 to 24
结局指标
主要结局
Serological and genetic studies at risk group
时间窗: 3 year
Serological and genetic testing in the laboratory. Screening for celiac disease for suspected celiac disease carried out by testing in an independent laboratory serological examinations (total IgA, AT to tissue transglutaminase IgA, AT to tissue transglutaminase IgG, AT to endomysium IgA); genetic screening - HLA-DQ2 / DQ8; IgE (wheat flour, F4).
Questioning of schoolchildren
时间窗: 2 year
Questionnaire by specially developed questionnaire. A structured questionnaire was used to collect data on symptoms and signs that are known to be associated with celiac disease. Each of the following statements begin with "Does your child have ...? " Scoring: Never=1; Seldom= 2; Frequent=3; A Lot=4; Don't Know=0; No=1; Yes=2 If the total score was 25 or more, then this respondent belongs to the high risk group for the development of celiac disease.
次要结局
未报告次要终点