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| Name | Class |
|---|---|
| BGI, China | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole vaginal | Active Comparator | Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) |
|
| Metronidazole vagianl and Probiotics(Umeta-mimi) | Experimental | Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole vaginal suppositories | Drug | Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) |
|
| 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 |
| 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 |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shangrong Fan, M.D. | Contact | 86-755-83923333 | 5505 | fanshangrong@163.com |
| Yiheng Liang, M.D. | Contact | 86-755-83923333 | 5505 | 13510331823@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruifang Wu, M.D. | Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hosptal | Recruiting | Shenzhen | Guangdong | 518036 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37575226 | Derived | Qi F, Fan S, Fang C, Ge L, Lyu J, Huang Z, Zhao S, Zou Y, Huang L, Liu X, Liang Y, Zhang Y, Zhong Y, Zhang H, Xiao L, Zhang X. Orally administrated Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 can restore the vaginal health of patients recovering from bacterial vaginosis. Front Immunol. 2023 Jul 27;14:1125239. doi: 10.3389/fimmu.2023.1125239. eCollection 2023. |
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| Metronidazole vaginal suppositories and Probiotics(Umeta-mimi) | Drug | Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days) |
|
|
| Recurrence of BV | Nugent score | 5-7 days after sixth menstruation after treatment |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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