Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Scoring atopic dermatitis (SCORAD) index
研究概览
简要总结
The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.
详细描述
The aim of the study is to investigate whether two different probiotics influence the clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the immunologic status and the intestinal microflora, inflammation and permeability will also be investigated.
Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups receiving either Lactobacillus acidophilus NCFM (1x10^10 Colony forming units), Bifidobacterium lactis Bi-07(1x10^10 Colony forming units) or placebo every day for 8 weeks.
At the beginning and at the end of the study the following analyses will be made:
- SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.
- Blood samples will be drawn to examine:
- Immunoglobulin E (IgE), total and specific for egg and milk.
- Eosinophil Cation Protein (ECP)
- Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma)
- Fecal samples will be collected to examine:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic dermatitis
排除标准
- •Chronic diseases other than atopic dermatitis
- •Chronic medication
结局指标
主要结局
Scoring atopic dermatitis (SCORAD) index
时间窗: 5 months
次要结局
- Interferon gamma (IFN-gamma)(6 months)
- Calprotectin(one year)
- Polymerase Chain Reaction (PCR)(8 months)
- Eosinophil Cation Protein (ECP)(7 months)
- Immunoglobulin E (IgE) Total(6 months)
- Immunoglobulin E (IgE) specific for Egg(6 months)
- Immunoglobulin E (IgE) specific for Milk(6 months)
- Interleukin-10 (Il-10)(6 months)
- Interleukin-12 (Il-12)(6 months)