Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition
研究概览
简要总结
Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 1 Day 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborns (< 2 weeks of life)
- •32 Weeks of Gestation,
- •weight < 1500g,
- •Enteral nutrition begun,
- •Clinical stability,
- •Signed consent form from both parents.
排除标准
- •newborns (>= 2 weeks of life),
- •weight >= 1500g,
- •pathology avoiding the start of the enteral nutrition,
- •other pathologies of those due to premature and its complications,
- •No signed consent form.
结局指标
主要结局
Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition
时间窗: at D14 and D21.
次要结局
- Age when Enteral Nutrition reaches 50% of Nutritional needs.
- Incidence of Nosocomial Infections.
- Composition of Colic Flora.
- Fecal Calprotectin as Index of Inflammation