A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Study Overview
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Brief Summary
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The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis

Detailed Description
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Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment

Official Title
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Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: Metronidazole vaginal suppositories
* Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 55 years old, with history of sexual activity, Amsel criterion for diagnosing BV Sign informed consent Exclusion Criteria: History of systemic organic diseases or psychiatric diseases Planning for or during pregnancy, lactation, menstruation within 5 days of onset of the disease, any antibiotics has been used Long-term use of contraceptives or immunosuppressant Anaphylactic constitution or allergic to known ingredients of research drugs No same fixed partner (RSP) before and after treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 vaginal<br>Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) | Drug: Metronidazole vaginal suppositories<br>* Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )<br>|
| Experimental: Metronidazole vagianl and Probiotics(Umeta-mimi)<br>Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days） | Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)<br>* Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）<br>* Other names: Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi）;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of BV | Assessments with different Units of Measure:clinical symptoms such as itching or burning; fishy smell; homogeneous thin vaginal discharge;Nugent score; pH>4.5; clue cell. | 14 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of BV | Nugent score | The first month after treatment | 
| Recurrence of BV | Nugent score | 5-7 days after third menstruation after treatment | 
| Recurrence of BV | Nugent score | 5-7 days after sixth menstruation after treatment |