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

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avva Rus, JSC
• Collaborators: Kirov Regional clinical Center of Perinatology; Kirov State Medical Academy
• Treatments: Metronidazole

Criteria

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.