MicrobiotaReuteri17NCT07404930
L. Reuteri SGL 01 in Nursing Mothers: Effects on Milk Microbiota and Neonatal Gut Colonization
A study testing probiotic Lactobacillus reuteri SGL 01 in people with Microbiota and Supplementation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Supplementation, Breastfeeding
- What is being tested?
- probiotic Lactobacillus reuteri SGL 01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primiparous women, mothers of full-term infants who are breastfed.
- Written informed consent;
- Age over 18 years.
Who cannot join
- Drug therapies that are contraindicated for breastfeeding
- Maternal conditions that are contraindicated for breastfeeding
- Neonatal formula milk feeding
- Antibiotic treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- probiotic Lactobacillus reuteri SGL 01
- Keywords
- microbiota, breastfeeding, neonates
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic Lactobacillus reuteri SGL 01Dietary supplement
5 drops of supplement based on lactic acid bacteria consisting exclusively of Lactobacillus Reuteri SGL 01
| Study group | Role | What they receive |
|---|---|---|
| Supplemented group | Active comparator | Daily oral supplementation with 1 × 10⁹ colony-forming units (CFU) of L. reuteri SGL 01 to breastfeeding mothers Receives: Dietary Supplement: probiotic Lactobacillus reuteri SGL 01 |
| Non-supplemented group | No intervention | Breastfeeding mothers who received no supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start16 Oct 2017
- Primary completion31 Jan 2021
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404930
- Sponsor's protocol ID
- Reuteri17
- Acronym
- Reuteri17
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With L. Reuteri SGL 01 in Nursing Mothers: Evaluation of the Microbiota in Breast Milk and Intestinal Colonization in Newborns
- ClinicalTrials.gov ID
- NCT07404930
- Acronym / sponsor ID
- Reuteri17 / Reuteri17
- Conditions
- Microbiota, Supplementation, Breastfeeding
- Keywords
- microbiota, breastfeeding, neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemented group | Active comparator | Dietary Supplement: probiotic Lactobacillus reuteri SGL 01Daily oral supplementation with 1 × 10⁹ colony-forming units (CFU) of L. reuteri SGL 01 to breastfeeding mothers |
| Non-supplemented group | No intervention | –Breastfeeding mothers who received no supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primiparous women, mothers of full-term infants who are breastfed.
- Written informed consent;
- Age over 18 years.
Key exclusion criteria (4 listed)
- Drug therapies that are contraindicated for breastfeeding
- Maternal conditions that are contraindicated for breastfeeding
- Neonatal formula milk feeding
- Antibiotic treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic Lactobacillus reuteri SGL 015 drops of supplement based on lactic acid bacteria consisting exclusively of Lactobacillus Reuteri SGL 01 | Dietary supplement | Supplemented group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic Lactobacillus reuteri SGL 01 in people with Microbiota and Supplementation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the concentration of Lactobacillus, Bifidobacterium, Clostridium and Bacteroides spp. in maternal milk samples between T0 and T1 (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.