Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity
研究概览
简要总结
This study aims to investigate the impact of being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children.
This is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. Regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.
详细描述
The primary hypothesis to be tested is that a strictly gluten free diet during the first three years of life with a slow introduction of gluten during the follow-up period will induce tolerance to gluten. A similar hypothesis is tested if a daily supply of two different lactobacillus (LB) strains can suppress an inflammatory response to gluten in the intestine by stimulating regulatory T-cells and reduced permeability of gluten peptides in the intestine.
The secondary hypothesis tested is that celiac disease can not be prevented, but the onset of the disease will be delayed in children returning to a gluten-containing diet after the intervention period (gluten free diet) or probiotic treatment) during the first three years of life. The intervention period is 3 years and the follow-up period is further 4 years.
The primary aim is to study the proportion of children who develop celiac disease autoimmunity and progression to celiac disease by the age of 3 years. Secondary aim is to study the proportion of children who developed celiac disease at the age of 7 years.
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)
入排标准
- 年龄范围
- 4 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children screened positive for human leucocyte antigen (HLA) DR3-DQ2/DR3-DQ2
- •Children must be enrolled to the study by 4 months of age (before gluten consumption has started).
排除标准
- •Congenital chronic disorder where intervention with diet or probiotics may be affected.
- •Written consent from both caregivers are missing
研究组 & 干预措施
Probiotics
Capsules with a combination of two probiotic bacteria with maize starch as excipient and at a total dose of 10(10) colony forming units (CFU)/capsule.
干预措施: Probiotics (Dietary Supplement)
Gluten free diet
Gluten free diet
干预措施: Gluten free diet (Other)
Placebo
Placebo capsules with maize starch and without any bacteria.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity
时间窗: from 4 months of age up until 7 years of age
Radioligand binding assays (RBA) will be used to measure tTG autoantibodies in serum samples collected every third months up until the age of 3 years and then annually up until the age of 7 years.
次要结局
- Number of children diagnosed with celiac disease(Up until 7 years of age)