Celiac Disease Prevention With Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Tissue transglutaminase autoantibodies (tTGA)
研究概览
简要总结
Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently available treatment is a gluten-free diet. Recent studies have shown several probiotics to carry properties that might positively influence the immunological activity in celiac patients.
The aim of the present study is to investigate how daily consumption of probiotics would affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac disease.
Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration of 6 months.
Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA using radioligand binding assays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Carrier of any of the HLA-types DQ2 and/or DQ8 associated with celiac disease.
- •Screened positive for tissue transglutaminase autoantibodies (tTGA) in at least 2 consecutive blood draws (<30U/ml).
- •No celiac disease diagnose
- •Currently on a normal gluten-containing diet
排除标准
- •Screened positive for Type 1 diabetes associated autoantibodies (GADA, IAA, IA-2A, ZnT8A).
结局指标
主要结局
Tissue transglutaminase autoantibodies (tTGA)
时间窗: 6 months
To study levels of tTGA in children with ongoing celiac disease autoimmunity
次要结局
未报告次要终点