Use of Probiotics Bifidobacterium Longum, Bifidobacterium Breve and Bifidobacterium Infantis in Treating Pediatric Food Allergy to Milk or Egg.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V
研究概览
简要总结
This study evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. The allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.
详细描述
This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.
It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).
Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy individuals (Group 3).
For all 40 patients:
- Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 will be evaluated;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Months 至 14 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 10 and 14 months
排除标准
- •gastrointestinal disease in progress or appearance in the last 30 days
- •metabolic diseases
- •antibiotic treatment in the 2 weeks prior to the start of the study;
- •intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.
研究组 & 干预措施
Allergic Children
Allergic children to milk or egg, aged between 10 and 14 months, confirmed by double-blind oral provocation test against placebo.
Intervention: 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63
干预措施: Multi-strain probiotic (Dietary Supplement)
Not confirmed Allergic Children
Sensible children to milk or egg, aged between 10 and 14 months, not confirmed by double-blind oral provocation test against placebo.
Controls
Healthy controls ages between 10 and 14 months
结局指标
主要结局
Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V
时间窗: 2 years
It will be indicated number of cells per ul of stool.
次要结局
- Stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V after multi-strain probiotic administration.(2 years)
研究者
Alessandro Giovanni Fiocchi
Director Clinical Research
Bambino Gesù Hospital and Research Institute