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| Name | Class |
|---|---|
| Kirov State Medical Academy | UNKNOWN |
| Kirov Regional clinical Center of Perinatology | UNKNOWN |
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This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis. Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose. It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis (metronidazole administered orally) improves women's general state, leads to better recovery of clinical, microbiological, biochemical and histological features of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactofiltrum | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactofiltrum + Metronidazole | Drug | Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported complaints | It's measured by seven ordinal (analog) scales (vaginal itch, vaginal burning, itch of external genitals, burning of external genitals, vaginal discharge, urination disorder,painful intercourse) with minimal value "0" (absent of the complaint-related discomfort) and maximal value "10" (maximal discomfort). | Days 0, 14 and 44 after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Gynaecological examination | It's represented by three ordinal scales with minimal value "0" ("not at all") and maximal value "3" ("severe"). They are measured by physician. | Days 0, 14 and 44 after start of intervention |
| Microscopy of vaginal discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyudmila Kobeleva, MD, PhD | Contact | +7-495-9567559 | kobeleva@leksir.ru | |
| Nickolay A. Kryuchkov, MD, PhD, MPH | Contact | +7-495-9567559 | nkryuchkov@leksir.ru |
| Name | Affiliation | Role |
|---|---|---|
| Lyudmila Kobeleva, MD, PhD | Avva Rus, JSC | Study Director |
| Sergey Dvoryanskiy, MD, DrSc | Kirov State Medical Academy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirov State Medical Academy | Recruiting | Kirov | Kirov Oblast | 610027 | Russia |
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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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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Metronidazole | Drug | Metronidazole 500 mg 1 tablet BID for 7 days per os |
|
| Days 0, 14 and 44 after start of intervention |
| Microbiological examination of vaginal discharge | Days 0, 14 and 44 after start of intervention |
| pH-test of vaginal discharge | Days 0, 14 and 44 after start of intervention |
| Microbiological feces analysis | Days 0, 14 and 44 after start of intervention |
| Blood test | Days 0, 14 and 44 after start of intervention |
| Urine test | Days 0, 14 and 44 after start of intervention |
| Kirov Regional Clinical Center of Perinatology | Recruiting | Kirov | Kirov Oblast | 610048 | Russia |
|
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |