NCT04165551

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

May 13, 2020

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

November 14, 2019

Last Update Submit

May 12, 2020

Conditions

Streptococcus Agalactiae

Keywords

Streptococcus agalactiaeProbioticsPrevention

Outcome Measures

Primary Outcomes (1)

  • Detection of Streptococus agalactiae in vaginal exudate

    It will be determined the presence of S. agalactiae in vaginal exudate

    8 weeks

Secondary Outcomes (1)

  • Cuantification of bacterial populations in vaginal exudate

    8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Volunteers will take 1 capsule per day containing 6x109 cfu of Lactobacillus BSL\_PS71 in maltodextrin.

Biological: Probiotic

Placebo

PLACEBO COMPARATOR

Volunteers will take 1 capsule per day containing maltodextrin.

Biological: Placebo

Interventions

ProbioticBIOLOGICAL

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

Probiotic
PlaceboBIOLOGICAL

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

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Test positive for S. agalactiae in vaginal exudate
  • Accept freely to participate in the study and sign the informed consent document

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biosearch Life

Granada, Andalusia, 18004, Spain

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Federico García, PhD

    Head of the Microbiology Service at the San Cecilio Hospital (Granada, Spain)

    STUDY CHAIR

Central Study Contacts

Fonollá Joya, PhD

CONTACT

+34618738539Juristo.FonollaJoya@biosearchlife.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

October 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 10, 2020

Last Updated

May 13, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)