Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse event
研究概览
简要总结
The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.
Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term newborn
- •Adeguate for gestational age
- •Born by elective cesarean section
- •Otherwise healthy newborn
排除标准
- •major acute or chronic disease
- •use of probiotics/antibiotics
- •gastrointestinal malformation, cystic fibrosis, other genetic diseases
- •concurrent participation in other clinical trials
结局指标
主要结局
Number of participants with treatment-related adverse event
时间窗: During 21 days after supplementation
A structured diary on possible treatment-related adverse event will be given to mothers.
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
时间窗: 21 days after supplementation start
To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology. Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample.
次要结局
未报告次要终点
研究者
Prof. Maria Elisabetta Baldassarre
Principal Investigator
Policlinico Hospital