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We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).
Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.
Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.
We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole Oral | Active Comparator | Metronidazole Oral |
|
| "Metronidazole" and "Lactobacillus" | Active Comparator | "Metronidazole" and "Lactobacillus" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole Oral | Drug | Oral metronidazole 400 mg BID for 7 days at first month. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate of BV | Nugent score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of BV | Nugent score | 12 weeks |
| Recurrence of BV | Nugent score | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shangrong Fan, M.D. | Peking University Shenzhen Hospital | Principal Investigator |
| Salvatore Giovanni Vitale, M.D. | Department of Human Pathology in Adulthood and Childhood, University of Messina (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Obstetrics and Gynecology | Shenzhen | Guangdong | 518036 | China |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| C100843 | Lacteol |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| "Metronidazole" and "Lactobacillus" |
| Drug |
Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month. |
|
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |