Streptococcus AgalactiaePhase 1NCT04165551
Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.
A Phase 1 study testing Probiotic in people with Streptococcus Agalactiae, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Agalactiae
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 10 Sep 2020
- Phase
- Phase 1
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Test positive for S. agalactiae in vaginal exudate
- Accept freely to participate in the study and sign the informed consent document
Who cannot join
- Consumption of probiotic supplements
- Antibiotic use in the period of 2 weeks before the start of the study
- Being pregnant or intending to get pregnant in the next 8 weeks
- Being allergic to any group of antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Controlled, Parallel Groups Study for the Evaluation of the Effects of the Consumption of Lactobacillus BSL_PS71 on the Load of Streptococcus Agalactiae on Vaginal Mucosa.
The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.
Read the detailed description
Group B streptococci (Streptococcus agalactiae) are found in the vaginal microbiota in 10-30% of women without showing signs of infection. However, during delivery, it can be transmitted to the baby and, although in most cases it does not lead to disease, in a percentage of 5% of babies it causes serious infections that can trigger the death of the baby. In order to avoid this risk, a protocol of intra-partum preventive administration of antibiotics was implanted decades ago in women with a positive vaginal culture for this species in the weeks before birth. Taking into account the high percentage of women who show positive culture, this represents a high percentage of women who receive preventive antibiotic treatment with the consequences that this has for the mother's and baby's microbiota, as well as contributing to the generation of antibiotic resistance, a serious problem for today's society.
The fecal microbiota is considered a source of bacteria for the vaginal microbiota. In fact, women who present S. agalactiae in the vaginal microbiota also have it in stool. Given the demonstrated ability of Lactobacillus to control certain bacterial populations, the ability of a battery of Lactobacillus strains to inhibit the growth of S. agalactiae in the context of the fecal microbiota was analyzed. From these tests the strain Lactobacillus BSL_PS71 was selected for its antibacterial capacity against S. agalactiae.
- Conditions
- Streptococcus Agalactiae
- Being tested
- Probiotic, Placebo
- Keywords
- Streptococcus agalactiae, ProbioticsPrevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticBiological
Volunteers will take 1 capsule a day of the Probiotic during lunch without any restrictions on diet or lifestyle.
PlaceboBiological
Volunteers will take 1 capsule a day of the Placebo during lunch without any restrictions on diet or lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Volunteers will take 1 capsule per day containing 6x109 cfu of Lactobacillus BSL_PS71 in maltodextrin. Receives: Biological: Probiotic |
| Placebo | Placebo comparator | Volunteers will take 1 capsule per day containing maltodextrin. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Streptococus agalactiae in vaginal exudate
It will be determined the presence of S. agalactiae in vaginal exudate
Measured: 8 weeks
Secondary outcomes (1)
Cuantification of bacterial populations in vaginal exudate
It will be cuantified the bacterial populations in vaginal exudate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Oct 2019
- Primary completion1 Sep 2020
- Study completion10 Sep 2020
Why it stopped: The study was terminated due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus AgalactiaeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federico García García, PhD
- Responsible party
- Sponsor
- Investigators
- Federico García, PhD, Study chair, Head of the Microbiology Service at the San Cecilio Hospital (Granada, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165551
- Sponsor's protocol ID
- P048
- Status last verified
- Aug 2019
- First submitted
- 14 Nov 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled, Parallel Groups Study for the Evaluation of the Effects of the Consumption of Lactobacillus BSL_PS71 on the Load of Streptococcus Agalactiae on Vaginal Mucosa.
- ClinicalTrials.gov ID
- NCT04165551
- Acronym / sponsor ID
- P048
- Conditions
- Streptococcus Agalactiae
- Keywords
- Streptococcus agalactiae, ProbioticsPrevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Collaborators
- Federico García García, PhD
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 18 Nov 2019 (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 objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.
Detailed description
Group B streptococci (Streptococcus agalactiae) are found in the vaginal microbiota in 10-30% of women without showing signs of infection. However, during delivery, it can be transmitted to the baby and, although in most cases it does not lead to disease, in a percentage of 5% of babies it causes serious infections that can trigger the death of the baby. In order to avoid this risk, a protocol of intra-partum preventive administration of antibiotics was implanted decades ago in women with a positive vaginal culture for this species in the weeks before birth. Taking into account the high percentage of women who show positive culture, this represents a high percentage of women who receive preventive antibiotic treatment with the consequences that this has for the mother's and baby's microbiota, as well as contributing to the generation of antibiotic resistance, a serious problem for today's society.
The fecal microbiota is considered a source of bacteria for the vaginal microbiota. In fact, women who present S. agalactiae in the vaginal microbiota also have it in stool. Given the demonstrated ability of Lactobacillus to control certain bacterial populations, the ability of a battery of Lactobacillus strains to inhibit the growth of S. agalactiae in the context of the fecal microbiota was analyzed. From these tests the strain Lactobacillus BSL_PS71 was selected for its antibacterial capacity against S. agalactiae.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: ProbioticVolunteers will take 1 capsule per day containing 6x109 cfu of Lactobacillus BSL_PS71 in maltodextrin. |
| Placebo | Placebo comparator | Biological: PlaceboVolunteers will take 1 capsule per day containing maltodextrin. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Test positive for S. agalactiae in vaginal exudate
- Accept freely to participate in the study and sign the informed consent document
Key exclusion criteria (4 listed)
- Consumption of probiotic supplements
- Antibiotic use in the period of 2 weeks before the start of the study
- Being pregnant or intending to get pregnant in the next 8 weeks
- Being allergic to any group of antibiotics
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 |
|---|---|---|
| ProbioticVolunteers will take 1 capsule a day of the Probiotic during lunch without any restrictions on diet or lifestyle. | Biological | Probiotic |
| PlaceboVolunteers will take 1 capsule a day of the Placebo during lunch without any restrictions on diet or lifestyle. | Biological | Placebo |
Primary outcome
Detection of Streptococus agalactiae in vaginal exudate
Time frame: 8 weeks
It will be determined the presence of S. agalactiae in vaginal exudate
1 secondary outcome
Cuantification of bacterial populations in vaginal exudate
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Federico García, PhD study chair
Head of the Microbiology Service at the San Cecilio Hospital (Granada, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotic in people with Streptococcus Agalactiae, run by Biosearch S.A. at 1 site in Spain.
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 2 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: stopped early, as of the sponsor's last update on 8 Oct 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to low enrollment). Results are not available in the source record.
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?
Detection of Streptococus agalactiae in vaginal exudate (time frame: 8 weeks). 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 8 Oct 2026.