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Sponsors and Collaborators: |
University Ghent IWT |
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Information provided by: | University Ghent |
ClinicalTrials.gov Identifier: | NCT00752193 |
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.
Condition | Intervention |
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Bacterial Vaginosis |
Other: Probiotic lactobacilli Other: Placebo |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System |
Estimated Enrollment: | 206 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Probiotic lactobacilli
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Other: Probiotic lactobacilli
Probiotic lactobacilli in combination with antibiotic therapy
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2: Placebo Comparator
Placebo
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Other: Placebo
Placebo in combination with antibiotic therapy
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marleen Temmerman, MD, PhD | Marleen.temmerman@ugent.be |
Belgium | |
University Hospital Ghent | |
Ghent, Belgium, 9000 |
Principal Investigator: | Marleen Temmerman, MD, PhD | University Hospital, Ghent |
Responsible Party: | University Ghent ( Marleen Temmerman ) |
Study ID Numbers: | 2008/438 |
Study First Received: | September 11, 2008 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00752193 |
Health Authority: | Belgium: Institutional Review Board |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis Vaginal Diseases |