A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis

Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis

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.

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.