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

NCT07404930 | Completed

• 1 other identifier: Reuteri17
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

microbiota; breastfeeding; neonates

Outcome Measures

Primary Outcomes (2)

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

  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.

  30 days

• Changes in the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in neonatal fecal samples between T0 and T1

  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.

  30 days

Study Arms (2)

Supplemented group

ACTIVE COMPARATOR

Daily oral supplementation with 1 × 10⁹ colony-forming units (CFU) of L. reuteri SGL 01 to breastfeeding mothers

Dietary Supplement: probiotic Lactobacillus reuteri SGL 01

Non-supplemented group

NO INTERVENTION

Breastfeeding mothers who received no supplementation

Interventions

probiotic Lactobacillus reuteri SGL 01 DIETARY_SUPPLEMENT

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

Supplemented group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Irccs Aoubo

Bologna, BO, 40131, Italy

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neonatology unit

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 12, 2026
• Study Start: October 16, 2017
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

IT (1)