NCT04165551

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Streptococcus Agalactiae

Interventions

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

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-09-01
• Completion: 2020-09-10
• First posted: 2019-11-18
• Last updated: 2020-05-13

Locations

1 site across 1 country: Spain