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

Phase 2

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Lactofiltrum + Metronidazole; Drug: Metronidazole

• Registration Number: NCT01089348
• Lead Sponsor: Avva Rus, JSC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Status Verified: 2010-07
• Study Start: 2010-07
• Last Update Submitted: 2010-07-20
• Last Update Posted: 2010-07-21
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactofiltrum	Lactofiltrum + Metronidazole	-
Control	Metronidazole	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Microscopy of vaginal discharge	Days 0, 14 and 44 after start of intervention
Microbiological feces analysis	Days 0, 14 and 44 after start of intervention
Urine test	Days 0, 14 and 44 after start of intervention

Trial Locations

Locations (2)

Kirov Regional Clinical Center of Perinatology; 🇷🇺 Kirov, Kirov oblast, Russian Federation

Kirov State Medical Academy; 🇷🇺 Kirov, Kirov oblast, Russian Federation