A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- SCORAD score
研究概览
简要总结
The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.
详细描述
Probiotics were also shown to reduce severity of AEDS when administered to infants with early onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established AEDS. In these studies, administration of Lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S aureus growth among Lactobacillus species in our preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide a more objective evidence for the beneficial role of this probiotic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with atopic dermatitis present for at least 6 months before inclusion
- •a total SCORAD score above 25
- •a change in a total SCORAD score of not more than 10% within 2 weeks
排除标准
- •patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months
研究组 & 干预措施
Lactobacillus sakei KCTC 10755BP
干预措施: probiotic L sakei KCTC 10755BP (Dietary Supplement)
microcrystalline cellulose
干预措施: microcrystalline cellulose (placebo) (Dietary Supplement)
结局指标
主要结局
SCORAD score
时间窗: 12 weeks
次要结局
- Chemokine levels(12 weeks)
