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| Name | Class |
|---|---|
| ZhuHai Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus cispatus | Experimental | 10^9 cfu,5 days |
|
| Placebo | Placebo Comparator | 0 cfu,5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus cispatus | Other | 10^9 cfu,5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| BV recurrence rate | Primary Outcome Measure | month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| vaginal secretions 16s rRNA gene sequencing | Secondary Outcome Measures | 2 weeks,month 1,month 3、month 6、month 12 |
| BV recurrence rate | Secondary Outcome Measures |
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Inclusion Criteria:
1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muxuan Chen, Doctor | Contact | +8613580561916 | muxuanchen@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongwei Zhou, Professor | Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhuhai People'S Hospital | Recruiting | Zhuhai | Guangdong | 519050 | China |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| placebo |
| Other |
0 cfu,5 days |
|
| 2 weeks,month 1,month 3、month 6 |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |