NCT07404930

L. Reuteri SGL 01 in Nursing Mothers: Effects on Milk Microbiota and Neonatal Gut Colonization

Supplementation With L. Reuteri SGL 01 in Nursing Mothers: Evaluation of the Microbiota in Breast Milk and Intestinal Colonization in Newborns

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Microbiota
• Supplementation
• Breastfeeding

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotic Lactobacillus reuteri SGL 01	5 drops of supplement based on lactic acid bacteria consisting exclusively of Lactobacillus Reuteri SGL 01

Timeline

• Start date: 2017-10-16
• Primary completion: 2021-01-31
• Completion: 2025-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Italy