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

Streptococcus Agalactiae Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04165551
• Other study ID #: P048
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: August 2019
• Source: Biosearch S.A.
• Contact: Fonollá Joya, PhD
• Phone: +34618738539
• Email: Juristo.FonollaJoya[@]biosearchlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 10, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Streptococcus Agalactiae

Intervention

Biological:
• Probiotic
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 a day of the Placebo during lunch without any restrictions on diet or lifestyle.

Locations

Country	Name	City	State
Spain	Biosearch Life	Granada	Andalucia

Sponsors (2)

Lead Sponsor	Collaborator
Biosearch S.A.	Federico García García, PhD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Streptococus agalactiae in vaginal exudate	It will be determined the presence of S. agalactiae in vaginal exudate	8 weeks
Secondary	Cuantification of bacterial populations in vaginal exudate	It will be cuantified the bacterial populations in vaginal exudate	8 weeks