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.

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.

Study Overview

• Status: Unknown
• Conditions: Streptococcus Agalactiae
• Intervention / Treatment: Biological: Probiotic; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fonollá Joya, PhD; Phone Number: +34618738539; Email: Juristo.FonollaJoya@biosearchlife.com

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18004
      • Recruiting
      • Biosearch Life
      • Contact: Juristo Fonolla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Collaborators: Federico García García, PhD
• Investigators: Study Chair: Federico García, PhD, Head of the Microbiology Service at the San Cecilio Hospital (Granada, Spain)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 10, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Streptococcus agalactiae; ProbioticsPrevention
• Other Study ID Numbers: P048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No