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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: Lactofiltrum + Metronidazole
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactofiltrum<br> | Drug: Lactofiltrum + Metronidazole<br>* Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os<br>|
| Active Comparator: Control<br> | Drug: Metronidazole<br>* Metronidazole 500 mg 1 tablet BID for 7 days per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Days 0, 14 and 44 after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gynaecological examination | It's represented by three ordinal scales with minimal value 0 (not at all) and maximal value 3 (severe). They are measured by physician. | Days 0, 14 and 44 after start of intervention | 
| Microscopy of vaginal discharge |  | Days 0, 14 and 44 after start of intervention | 
| 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 | 
| Microbiological feces analysis |  | Days 0, 14 and 44 after start of intervention | 
| Blood test |  | Days 0, 14 and 44 after start of intervention | 
| Urine test |  | Days 0, 14 and 44 after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginosis, Bacterial, Prebiotics, Lactofiltrum, Therapy