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-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).

Detailed Description
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Studies have shown that oral probiotics 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-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis 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, the first month after treatment, the third month after treatment and the sixth month 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: Probiotics and Metronidazole
* Drug: Metronidazole Vaginal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 65 years old, with history of sexual activity, premenopausal women； Nugent Score ≥ 7 for diagnosing BV； Sign informed consent. Exclusion Criteria: mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Probiotics and Metronidazole<br>Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) | Drug: Probiotics and Metronidazole<br>* Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)<br>* Other names: Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories;|
| Active Comparator: Metronidazole vaginal<br>Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) | Drug: Metronidazole Vaginal<br>* Metronidazole Suppositories,qd, 7 days<br>* Other names: Metronidazole Suppositories;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Related Clinical Signs or Symptoms at Baseline | Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a fishy smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated. | 1 day before starting treatment | 
| Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up | Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a fishy smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated. | the 30th day after starting treatment | 
| Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up | Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a fishy smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated. | the 90th day after starting treatment | 
| Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up | A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. | the 30th day after starting treatment | 
| Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up | A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. | the 90th day after starting treatment |