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

Study Overview
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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.

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.

Official Title
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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.

Conditions
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Streptococcus Agalactiae

Intervention / Treatment
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* Biological: Probiotic
* Biological: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Volunteers will take 1 capsule per day containing 6x109 cfu of Lactobacillus BSL_PS71 in maltodextrin. | Biological: Probiotic<br>* Volunteers will take 1 capsule a day of the Probiotic during lunch without any restrictions on diet or lifestyle.<br>|
| Placebo Comparator: Placebo<br>Volunteers will take 1 capsule per day containing maltodextrin. | Biological: Placebo<br>* Volunteers will take 1 capsule a day of the Placebo during lunch without any restrictions on diet or lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Streptococus agalactiae in vaginal exudate | It will be determined the presence of S. agalactiae in vaginal exudate | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuantification of bacterial populations in vaginal exudate | It will be cuantified the bacterial populations in vaginal exudate | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus agalactiae, ProbioticsPrevention