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

Avva Rus, JSC90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (2)

Kirov State Medical Academy

Kirov, Kirov Oblast, Russia

RECRUITING

Kirov Regional Clinical Center of Perinatology

Kirov, Kirov Oblast, Russia

RECRUITING

Outcomes

Primary Outcomes

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).