Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Study Overview
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Brief Summary
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The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

Detailed Description
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To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.

Official Title
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Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Dietary Supplement: probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Form. Subjects with bacterial vaginosis and Nugent score as 4-10 Subjects in age of 20-55 years old Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days) Forbidden sexual behavior was required 72 hours before all visits Exclusion Criteria: Subjects are pregnant, lactating or planning to become pregnant. Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.) Bleeding from genital tract of unknown aetiology. Congenital and acquired immunodeficiencies. Diabetes Mental illness Malignant tumor Application of NuvaRing hormonal contraceptive vaginal ring Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period. Mycotic vaginitis Antibiotic(unless indicated by PI) and steroids therapy during this trial. Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1. Participation in another clinical study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel, open lable Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VGA-1(Probiotics)<br>Lactobacillus rhamnosus and Lactobacillus acidophilus. | Dietary Supplement: probiotics<br>* Two capsules for daily<br>|
| Active Comparator: VGA-2(Probiotics)<br>Lactobacillus rhamnosus and Lactobacillus plantarum. | Dietary Supplement: probiotics<br>* Two capsules for daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nugent Score | The degree of decline for Nugent score | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH | Vaginal pH value changes | 4 weeks | 
| Vaginal secretions microflora | Changes in vaginal secretions microflora | 4 weeks |