Treatment of Screen-detected Celiac Disease in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Small-bowel mucosal morphology and inflammation
研究概览
简要总结
The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.
详细描述
Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive endomysial antibodies
排除标准
- •Previous celiac disease diagnosis
- •Significant clinical symptoms
- •Suspicion of any serious celiac disease-associated complication
- •Suspected or diagnosed severe illness other than celiac disease
- •Consuming oral corticosteroids or immune suppressants
- •Marked laboratory abnormalities
结局指标
主要结局
Small-bowel mucosal morphology and inflammation
时间窗: One year
次要结局
- Endomysial antibodies(one year)
- Tissue transglutaminase antibodies(one year)
- Antibodies to deamidated gliadin(one year)
- Intestinal tissue transglutaminase-specific IgA deposits(one year)
- Bone mineral density(one year)
- Body composition(one year)
- Health-related quality of life(one year)
- Laboratory parameters(one year)
研究者
Kalle Kurppa
M.D, Ph.D, Pediatrician
Tampere University Hospital