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Supplementation With L. Reuteri SGL 01 in Nursing Mothers: Evaluation of the Microbiota in Breast Milk and Intestinal Colonization in Newborns
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Irccs Aoubo
Bologna, BO, Italy
Start Date
October 16, 2017
Primary Completion Date
January 31, 2021
Completion Date
December 31, 2025
Last Updated
February 12, 2026
70
ACTUAL participants
probiotic Lactobacillus reuteri SGL 01
DIETARY_SUPPLEMENT
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04924712