Cytokine Profile in Children With Celiac Disease
Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease
Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of gluten and related prolamines in genetically susceptible individuals. Not only genetic but also environmental factors play an important role in CD pathogenesis. CD patients have imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces and biopsies.
Up till now, only effective treatment for CD is life long adherence to gluten free diet. If gluten free diet is not strict that leads over the years to complications of disease, such as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous recirculation of activated immune cells between the inflamed organ and the periphery. To avoid complications of disease in long term the investigators want to test specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as anti-inflammatory.
Hypothesis
- Children with celiac disease on gluten free diet have a higher level of pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy controls.
- 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase.
In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups:
- Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months.
- Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months.
- Group: 20 healthy children
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- celiac disease on gluten free diet
Exclusion Criteria:
- acute or chronic diseases,
- permanent use of medication and
- ingestion of antibiotics at least one month prior to study
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Bifidobacterium breve
Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months
|
|
|
有源比较器:Placebo
Placebo in the same powder packages as Bifidobacterium breve
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease
大体时间:3 months
|
3 months
|
合作者和调查者
调查人员
- 首席研究员:Martina Klemenak, md、University Medical Centre Maribor
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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