RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
69
Oil drops of L. reuteri containing 1x10\>8 CFU
Oil drops mimicking in consistency and flavor to experimental product
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, Mexico
Changes on fecal microbiome diversity at day 14
Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Time frame: 14 days
Changes on fecal microbiome abundance at day 14
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Time frame: 14 days
Changes on fecal microbiome stability at day 14
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Time frame: 14 days
Changes on fecal microbiome diversity at day 7, 30 and 60
Changes on abundance evaluated by Channon Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention
Time frame: 7, 30 and 60 days
Changes on fecal microbiome abundance at day 7, 30 and 60
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention
Time frame: 7, 30 and 60 days
Changes on fecal microbiome stability at day 7, 30 and 60
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention
Time frame: 7, 30 and 60 days
Changes on Salivary IgA levels
Levels of salivary IgA after 7,30 and 60 days after intervention
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Time frame: 7, 30 and 60 days
Frequency of Adverse Event
Frequency of adverse events reported after randomization and until finish the treatment (day 30)
Time frame: 30 days