Bacterial Vaginosis
Conditions
Brief summary
The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.
Detailed description
The volunteers will be recruited from the women who come to the hospital to do the bacterial vaginosis test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. Then, posterior fornix of vagina secretions will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment , Clue cell detection and amine test. After 2weeks ,1 month ,3 months,6 months,12 monthssince the entry, each volunteer will be asked to go back to research center to do the same sampling and examination as previously did in entry.
Interventions
OTHERLactobacillus cispatus
10\^9 cfu,5 days
OTHERplacebo
0 cfu,5 days
Sponsors
ZhuHai Hospital
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1\. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis
Exclusion criteria
1. During pregnancy, or within 8 weeks after delivery; 2. presence of systemic diseases (such as SLE, malignant tumors, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BV recurrence rate | month 12 | Primary Outcome Measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vaginal secretions 16s rRNA gene sequencing | 2 weeks，month 1，month 3、month 6、month 12 | Secondary Outcome Measures |
| BV recurrence rate | 2 weeks，month 1，month 3、month 6 | Secondary Outcome Measures |
Countries
China
Contacts
Primary ContactMuxuan Chen, Doctor
Outcome results
None listed