Evaluation of the Influence of Bifidobacterium on the Infants With Food Allergic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The milk related symptom score at the 4th week
研究概览
简要总结
Infant food protein allergy is the most common allergic disease in children, which can lead to infantile-specific dermatitis, intestinal inflammation, and so on. Dietary avoidance is a common strategy for food protein allergy in infants and young children. However, the hidden etiology of food protein allergy or multiple food allergies often leads to poor efficacy. The aim of this study is to observe the clinical effectiveness of Bifidobacterium intervention on food allergy.
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
- None
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0 -12 months infant
- •Infants that are allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg, soy or wheat) and is following an elimination diet to at least one of these allergens.
排除标准
- •Patients had used probiotics within 1 month prior to the study
- •Allergy or intolerance to probiotics or their excipient
- •Serious primary diseases of the cardiovascular, nervous, respiratory,hepatobiliary immunology，and endocrine systems;
研究组 & 干预措施
Dietary avoidance for allergy food
strict avoidance of the specific allergenic food
干预措施: allergy food avoidance (Other)
bifidobacterium intervention
Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food
干预措施: Bifidobacterium M-16V (Dietary Supplement)
Healthy control
without intervention
结局指标
主要结局
The milk related symptom score at the 4th week
时间窗: Treatment for 4-week
Compare the clinical symptoms of infants at the 4th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
次要结局
- The milk related symptom score at the 8th week(Treatment for 8-week)
- The milk related symptom score at 12th week(Treatment for 12-week)