Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.
研究概览
简要总结
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 & Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
详细描述
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 & Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Minute 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation.
- •Written informed consent signed by the parent or legal guardian.
- •Tolerate enteral feeding, at least 10mL / kg / day.
- •Postnatal age ≤ 5 days
排除标准
- •Child with malformations
- •With short bowel syndrome or any surgery in the gastrointestinal tract
- •With defect in the intestinal epithelial barrier
研究组 & 干预措施
Lactobacillus PS11603 & Bifidobacterium PS10402
A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus PS11603 and 1*10E8 CFU of Bifidobacterium PS10402 in 1 vial will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age.
干预措施: Lactobacillus PS11603 & Bifidobacterium PS10402 (Dietary Supplement)
Placebo
1 vial of Placebo will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.
时间窗: 2 months
Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants
次要结局
未报告次要终点