Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Changes on fecal microbiome abundance at day 14
研究概览
简要总结
RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section
详细描述
RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding process will be structured centrally. The oil drops of active are contained in an ambar flask. Placebo consistency, smell, flavor and container are identical to active product
入排标准
- 年龄范围
- 12 Hours 至 36 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age >37weeks +0 days and <39 weeks +0 days
- •Birth weight appropriate for gestational age (AGA) or Large for Gestational Age (LGA)
- •Apgar score 8 or greater
- •Children will receive more than 50% of the feeding occasions with human breastmilk
- •Mothers will have the intention to exclusively or predominantly breastfeed the subject. On the diary report form mother will report day by day the frequency of human lactation and the frequency and amount of infant formula.
- •Readiness and the opportunity for parents to fill out a study diary, questionnaires.
- •Parent(s) are willing to postpone major changes in the infant feeding mode, and
- •Written informed consent from parents
排除标准
- •Older than 24 hours after birth when given the first dose of investigational product
- •Any kind of chronic or acute diseases during pregnancy that can modify fecal microbiota in children, e.g. gestational diabetes, pre-clampsia, gastrointestinal disease
- •Congenital malformations or anomalies
- •Maternal use of antibiotics from gestational week 33 and throughout the study period.
- •Maternal use of probiotics from gestational week 33 and throughout the study period.
- •Maternal severe obesity at inclusion or at delivery evaluated using Rosso Madrones centiles
- •Infant use of antibiotics throughout the study period.
- •Infant use of probiotics throughout the study period, including infant formula and/or supplementation.
- •Infants carrying out general anesthesia
- •Meconium aspiration syndrome
- •History of premature disruption of membranes for >24h
- •Participation in other clinical trials
研究组 & 干预措施
Placebo probiotics
Placebo for probiotics, pols drops similar in consistency and flavor as experimental product
干预措施: Placebo for Probiotics (Other)
Lactobacillus reuteri DSM17038
Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days
干预措施: Lactobacillus reuteri DSM17038 (Dietary Supplement)
结局指标
主要结局
Changes on fecal microbiome abundance at day 14
时间窗: 14 days
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Changes on fecal microbiome stability at day 14
时间窗: 14 days
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Changes on fecal microbiome diversity at day 14
时间窗: 14 days
Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
次要结局
- Changes on fecal microbiome diversity at day 7, 30 and 60(7, 30 and 60 days)
- Changes on fecal microbiome abundance at day 7, 30 and 60(7, 30 and 60 days)
- Changes on fecal microbiome stability at day 7, 30 and 60(7, 30 and 60 days)
- Changes on Salivary IgA levels(7, 30 and 60 days)
- Frequency of Adverse Event(30 days)
研究者
Pedro Gutierrez Castrellon
Head of Translational Research Center for Mother-Child Health
Innovacion y Desarrollo de Estrategias en Salud