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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
Placebo in drop formulation. 5 drop/daily for 21 days
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, Italy
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
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.
Time frame: 21 days after supplementation start
Number of participants with treatment-related adverse event
A structured diary on possible treatment-related adverse event will be given to mothers.
Time frame: During 21 days after supplementation
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