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

Biosearch Life

Status and phase: Unknown; Phase 1

Conditions: Streptococcus Agalactiae

Treatments: Biological: Probiotic; Biological: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04165551

P048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Volunteers will take 1 capsule per day containing 6x109 cfu of Lactobacillus BSL_PS71 in maltodextrin.

Treatment:

Biological: Probiotic

Placebo

Placebo Comparator group

Description:

Volunteers will take 1 capsule per day containing maltodextrin.

Treatment:

Biological: Placebo