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Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.

NCT00752193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2021-11-19

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and the efficacy of vaginally administered probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with microbiologically defined bacterial vaginosis.

Conditions

  • Bacterial Vaginosis

Interventions

OTHER

Probiotic lactobacilli

Probiotic lactobacilli in combination with antibiotic therapy

OTHER

Placebo

Placebo in combination with antibiotic therapy

Sponsors & Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER

  • University Ghent

    lead OTHER

Principal Investigators

  • Marleen Temmerman, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium

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 NCT00752193 on ClinicalTrials.gov