Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)
研究概览
简要总结
The purpose of this study is to determine the prevalence of previously undiagnosed coeliac disease based on a health survey from Tromsø, Norway. Moreover, the health impact of undiagnosed coeliac disease will be examined.
详细描述
Few population-based studies have examined the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed coeliac disease is much higher than the number who know their diagnosis.
The purpose of this study is to determine the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health.
In a health survey of the population of Tromsø Norway, serological markers of coeliac disease (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed. Individuals with increased level of one of these markers, will be invited for upper endoscopy with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons with screen detected coeliac disease, will be advised to start a gluten free diet.
Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.
- At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy verified coeliac disease and compared with a group of healthy control persons from the health-survey cohort.
- In a prospective study of the persons with screen detected coeliac disease, health status (GSRS) and Quality of Life will be compared before and after one year on a gluten free diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and biopsy verified coeliac disease
排除标准
- •Previously diagnosed coeliac disease
结局指标
主要结局
Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)
时间窗: 7 days
The Gastrointestinal symptoms rating scale (GSRS) is a disease-specific instrument with 15 items combined into five major domains: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The scale assesses symptom severity using a seven-grade Likert scale, ranging from 1 (no discomfort at all) to 7 (very severe discomfort). A lower score indicates less symptoms. GSRS is obtained at first visit and at follow-up (\>one year) to evaluate change in one of the five domain scores or total score (primary outcome)
次要结局
- Self-reported change in energy(One year)
- Self-reported change in abdominal complaints(One year)
- Quality of life score: Psychological General Well-Being Index (PGWBI)(7 days)