Bacterial Vaginosis
Conditions
Keywords
Vaginosis, Bacterial, Prebiotics, Lactofiltrum, Therapy
Brief summary
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.
Interventions
DRUGLactofiltrum + Metronidazole
Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
DRUGMetronidazole
Metronidazole 500 mg 1 tablet BID for 7 days per os
Sponsors
Kirov State Medical Academy
Kirov Regional clinical Center of Perinatology
Avva Rus, JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* bacterial vaginosis.
Exclusion criteria
* pregnancy and breast-feeding; * concomitant infection diseases; * systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion; * application of intravaginal medicines during participation in the study; * severe diseases; * renal and hepatic failure; * application of pre-, probiotics and antibiotics 2 weeks before inclusion or during participation in the study; * participation in other clinical study 1 month before inclusion or during participation in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported complaints | Days 0, 14 and 44 after start of intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microscopy of vaginal discharge | 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 | — |
| Gynaecological examination | Days 0, 14 and 44 after start of intervention | It's represented by three ordinal scales with minimal value 0 (not at all) and maximal value 3 (severe). They are measured by physician. |
| Blood test | Days 0, 14 and 44 after start of intervention | — |
| Urine test | Days 0, 14 and 44 after start of intervention | — |
| Microbiological feces analysis | Days 0, 14 and 44 after start of intervention | — |
Countries
Russia
Contacts
Primary ContactLyudmila Kobeleva, MD, PhD
Backup ContactNickolay A. Kryuchkov, MD, PhD, MPH
Outcome results
None listed