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Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.

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.

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04165551
Enrollment
60
Registered
2019-11-18
Start date
2019-10-01
Completion date
2020-09-10
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Streptococcus Agalactiae

Keywords

Streptococcus agalactiae, ProbioticsPrevention

Brief 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.

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.

Interventions

BIOLOGICALProbiotic

Volunteers will take 1 capsule a day of the Probiotic during lunch without any restrictions on diet or lifestyle.

BIOLOGICALPlacebo

Volunteers will take 1 capsule a day of the Placebo during lunch without any restrictions on diet or lifestyle.

Sponsors

Federico García García, PhD
CollaboratorUNKNOWN
Biosearch S.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Test positive for S. agalactiae in vaginal exudate * Accept freely to participate in the study and sign the informed consent document

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Detection of Streptococus agalactiae in vaginal exudate8 weeksIt will be determined the presence of S. agalactiae in vaginal exudate

Secondary

MeasureTime frameDescription
Cuantification of bacterial populations in vaginal exudate8 weeksIt will be cuantified the bacterial populations in vaginal exudate

Countries

Spain

Contacts

Primary ContactFonollá Joya, PhD
Juristo.FonollaJoya@biosearchlife.com+34618738539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026