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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-09-10

Brief Summary

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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.

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Detailed Description

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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

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Streptococcus Agalactiae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Volunteers will take 1 capsule per day containing 6x109 cfu of Lactobacillus BSL\_PS71 in maltodextrin.

Group Type EXPERIMENTAL

Probiotic

Intervention Type BIOLOGICAL

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

Placebo

Volunteers will take 1 capsule per day containing maltodextrin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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Probiotic

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes