A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis (LF-BV-09)
The recruitment status of this study is unknown because the information has not been verified recently.
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 Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Microbiological examination of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ] [ Designated as safety issue: No ]
- pH-test of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ] [ Designated as safety issue: No ]
- Microbiological feces analysis [ Time Frame: Days 0, 14 and 44 after start of intervention ] [ Designated as safety issue: No ]
- Blood test [ Time Frame: Days 0, 14 and 44 after start of intervention ] [ Designated as safety issue: Yes ]
- Urine test [ Time Frame: Days 0, 14 and 44 after start of intervention ] [ Designated as safety issue: Yes ]
| 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 |
| Genders 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 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 | |
| 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 | |
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
No publications provided
| 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 |
| Health Authority: | Russia: Local Ethics Committee of Kirov State Medical Academy Russia: Local Ethics Committee of Kirov Regional clinical Center of Perinatology Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Federal Service on surveillance in Healthcare and Social development |
Keywords provided by Avva Rus, JSC:
|
Vaginosis, Bacterial Prebiotics Lactofiltrum Therapy |
Additional relevant MeSH terms:
|
Vaginitis Vaginosis, Bacterial Bacterial Infections Genital Diseases, Female Vaginal Diseases Metronidazole |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015