Trial | NCT01089348  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    90
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.
Study Started
Jul 31
2010
Primary Completion
Oct 31
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Jul 21
2010
Estimate

Drug Lactofiltrum + Metronidazole

Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os

Drug Metronidazole

Metronidazole 500 mg 1 tablet BID for 7 days per os

Lactofiltrum Experimental

Control Active Comparator

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.
No Results Posted