A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis (LF-BV-09)
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ClinicalTrials.gov Identifier: NCT01089348 |
Recruitment Status
: Unknown
Verified July 2010 by Avva Rus, JSC.
Recruitment status was: Recruiting
First Posted
: March 18, 2010
Last Update Posted
: July 21, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Vaginosis | Drug: Lactofiltrum + Metronidazole Drug: Metronidazole | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis |
Study Start Date : | July 2010 |
Estimated Primary Completion Date : | October 2010 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Lactofiltrum |
Drug: Lactofiltrum + Metronidazole
Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
|
Active Comparator: Control |
Drug: Metronidazole
Metronidazole 500 mg 1 tablet BID for 7 days per os
|
- Self-reported complaints [ Time Frame: 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).
- Gynaecological examination [ Time Frame: 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.
- Microscopy of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
- Microbiological examination of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
- pH-test of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
- Microbiological feces analysis [ Time Frame: Days 0, 14 and 44 after start of intervention ]
- Blood test [ Time Frame: Days 0, 14 and 44 after start of intervention ]
- Urine test [ Time Frame: Days 0, 14 and 44 after start of intervention ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089348
Contact: Lyudmila Kobeleva, MD, PhD | +7-495-9567559 | kobeleva@leksir.ru | |
Contact: Nickolay A. Kryuchkov, MD, PhD, MPH | +7-495-9567559 | nkryuchkov@leksir.ru |
Russian Federation | |
Kirov State Medical Academy | Recruiting |
Kirov, Kirov oblast, Russian Federation, 610027 | |
Contact: Sergey Dvoryanskiy, MD, DrSc +7-8332-277211 dvorsa@mail.ru | |
Principal Investigator: Sergey Dvoryanskiy, MD, DrSc | |
Kirov Regional Clinical Center of Perinatology | Recruiting |
Kirov, Kirov oblast, Russian Federation, 610048 | |
Contact: Nadezhda Yagovkina, MD, PhD +7-8332-523639 nadezhda-yagovkina@yandex.ru | |
Principal Investigator: Nadezhda Yagovkina, MD, PhD |
Study Director: | Lyudmila Kobeleva, MD, PhD | Avva Rus, JSC | |
Principal Investigator: | Sergey Dvoryanskiy, MD, DrSc | Kirov State Medical Academy |
Responsible Party: | Prof. Sergey Dvoryanskiy, Kirov State Medical Academy |
ClinicalTrials.gov Identifier: | NCT01089348 History of Changes |
Other Study ID Numbers: |
02/09-AVVA RUS |
First Posted: | March 18, 2010 Key Record Dates |
Last Update Posted: | July 21, 2010 |
Last Verified: | July 2010 |
Keywords provided by Avva Rus, JSC:
Vaginosis, Bacterial Prebiotics Lactofiltrum Therapy |
Additional relevant MeSH terms:
Vaginal Diseases Vaginosis, Bacterial Genital Diseases, Female Bacterial Infections Vaginitis |
Metronidazole Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |