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A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis (LF-BV-09)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Avva Rus, JSC.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Avva Rus, JSC
Collaborators:
Kirov State Medical Academy
Kirov Regional clinical Center of Perinatology
Information provided by:
Avva Rus, JSC
ClinicalTrials.gov Identifier:
NCT01089348
First received: March 17, 2010
Last updated: July 20, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Bacterial Vaginosis | Drug: Lactofiltrum + Metronidazole Drug: Metronidazole | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Avva Rus, JSC:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01089348
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089348
Contacts
| Contact: Lyudmila Kobeleva, MD, PhD | +7-495-9567559 | kobeleva@leksir.ru | |
| Contact: Nickolay A. Kryuchkov, MD, PhD, MPH | +7-495-9567559 | nkryuchkov@leksir.ru |
Locations
| 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 | |
Sponsors and Collaborators
Avva Rus, JSC
Kirov State Medical Academy
Kirov Regional clinical Center of Perinatology
Investigators
| Study Director: | Lyudmila Kobeleva, MD, PhD | Avva Rus, JSC |
| Principal Investigator: | Sergey Dvoryanskiy, MD, DrSc | Kirov State Medical Academy |
More Information
| Responsible Party: | Prof. Sergey Dvoryanskiy, Kirov State Medical Academy |
| ClinicalTrials.gov Identifier: | NCT01089348 History of Changes |
| Other Study ID Numbers: |
02/09-AVVA RUS |
| Study First Received: | March 17, 2010 |
| Last Updated: | July 20, 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 |
ClinicalTrials.gov processed this record on June 27, 2017