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

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.

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Key information

Conditions

Microbiota Behavior Breast Feeding Breastfeeding Feeding Behavior Supplementation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Irccs Aoubo

Bologna, BO, 40131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primiparous women, mothers of full-term infants who are breastfed.
Written informed consent;
Age over 18 years.

Exclusion criteria

Drug therapies that are contraindicated for breastfeeding
Maternal conditions that are contraindicated for breastfeeding
Neonatal formula milk feeding
Antibiotic treatments

Treatment and study plan

probiotic Lactobacillus reuteri SGL 01

Dietary Supplement

5 drops of supplement based on lactic acid bacteria consisting exclusively of Lactobacillus Reuteri SGL 01

Primary outcomes

Changes in the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in maternal milk samples between T0 and T1

Time frame: 30 days

Bacterial DNA was extracted from 2 mL of milk samples, stored at -80 °C after collection, using the QIAamp DNA Mini Kit (Qiagen, West Sussex, UK). Bacterial counts (log CFU/ml milk) were based on rRNA gene copy numbers retrieved from the rRNA copy number database. Mann-Whitney U test was used to compare the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in milk samples at T0 and T1 between the study groups. Wilcoxon signed rank test was used to compare the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in milk samples between T0 and T1 within each study group. Significance level was set at P <0.05.
Changes in the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in neonatal fecal samples between T0 and T1

Time frame: 30 days

Bacterial DNA was extracted from 250 mg of neonatal fecal samples, stored at -80 °C after collection, using the QIAamp DNA Mini Kit (Qiagen, West Sussex, UK). Bacterial counts (log CFU/g feces) were based on rRNA gene copy numbers retrieved from the rRNA copy number database. Mann-Whitney U test was used to compare the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in neonatal fecal samples at T0 and T1 between the study groups. Wilcoxon signed rank test was used to compare the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in fecal samples between T0 and T1 within each study group. Significance level was set at P <0.05.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: Reuteri17

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2025
First posted: Feb 12, 2026
Registry last updated: Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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