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Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers

NCT05688397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-07-20

No results posted yet for this study

Summary

Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Experimental 1

L. gasseri oral capsule once a day (1 x 10\^9 CFU/day) for 18 days starting the next day after menstruation is over

DIETARY_SUPPLEMENT

Experimental 2

L. gasseri and L. crispatus oral capsule once a day (1.5 x 10\^9 CFU/day) for 18 days starting the next day after menstruation is over

DIETARY_SUPPLEMENT

Placebo

One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over

Sponsors & Collaborators

  • AB Biotics, SA

    lead INDUSTRY

Principal Investigators

  • Ana Maria Aldea Perona, PhD · Instituto Hospital del Mar de Investigaciones Médicas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05688397 on ClinicalTrials.gov