L. Reuteri SGL 01 in Nursing Mothers: Effects on Milk Microbiota and Neonatal Gut Colonization
L. Reuteri SGL 01 in Nursing Mothers: Effects on Milk Microbiota and Neonatal Gut Colonization
NCT ID: NCT07404930 Phase: NA Status: COMPLETED Enrollment: 70 Completion: 2025-12-31
Conditions
Microbiota, Supplementation, Breastfeeding
Interventions
probiotic Lactobacillus reuteri SGL 01
Summary
The Reuteri17 study is a spontaneous, prospective, randomized intervention study designed to evaluate the effects of maternal supplementation with the probiotic Lactobacillus reuteri SGL 01 on the composition of the breast milk microbiota and subsequent intestinal colonization of the newborn.
The protocol involves the enrollment of 20 primiparous mothers of full-term, exclusively breastfed infants. Participants are divided into two groups: the first receives a daily supplement of 5 drops of Reuplus® (equivalent to 1 billion live cultures), while the second serves as a non-supplemented control group.
The effectiveness of the intervention is monitored through two sampling moments: at baseline (T0) and after 30 days of treatment (T1). Specifically, 20 ml samples of breast milk and fecal samples from the newborns are collected. Bacterial DNA is extracted from these biological matrices and analyzed using real-time PCR at the University of Bologna, with the aim of quantifying changes in the microbiota and the transfer of the probiotic strain.
To complete the investigation, mothers are given a nutritional questionnaire to correlate the results with dietary habits. The study aims to confirm that maternal oral supplementation can be an effective strategy for modulating the bacterial heritage of newborns during the first months of life.
Primary Outcome
Changes in the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in maternal milk samples between T0 and T1