Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

Study Overview
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Brief Summary
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We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Detailed Description
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Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported. We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Official Title
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A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis

Conditions
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Bacterial Vaginosis, Recurrence

Intervention / Treatment
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* Drug: Metronidazole Oral
* Drug: Metronidazole and Lactobacillus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women be at least 18 years of age Have symptoms of vaginal odor and or/discharge Meet the clinical (Amsel) criteria for BV Willing to participate in research Exclusion Criteria: Presence of another vaginal infection or STD Allergy to metronidazole Pregnant or nursing Use of oral or intravaginal antibiotics within the past 2 weeks HIV or other chronic disease Inability to keep return appointments Contraindications for Lactobacillus Vaginal Suppositories（those without sexual history）

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole Oral<br>Metronidazole Oral | Drug: Metronidazole Oral<br>* Oral metronidazole 400 mg BID for 7 days at first month.<br>|
| Active Comparator: Metronidazole and Lactobacillus<br>Metronidazole and Lactobacillus | Drug: Metronidazole and Lactobacillus<br>* Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of BV | Nugent score | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of BV | Nugent score | 12 weeks | 
| Recurrence of BV | Nugent score | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrence, Lactobacillus Vaginal Suppositories