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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

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.

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Detailed Description

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Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactofiltrum

Group Type EXPERIMENTAL

Lactofiltrum + Metronidazole

Intervention Type DRUG

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

Control

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

Metronidazole 500 mg 1 tablet BID for 7 days per os

Interventions

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Lactofiltrum + Metronidazole

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

Intervention Type DRUG

Metronidazole

Metronidazole 500 mg 1 tablet BID for 7 days per os

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No