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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
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Lactofiltrum + Metronidazole Drug: Metronidazole Phase 2 Phase 3

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Microscopy of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
  3. Microbiological examination of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
  4. pH-test of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
  5. Microbiological feces analysis [ Time Frame: Days 0, 14 and 44 after start of intervention ]
  6. Blood test [ Time Frame: Days 0, 14 and 44 after start of intervention ]
  7. Urine test [ Time Frame: Days 0, 14 and 44 after start of intervention ]

Eligibility Criteria

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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

Information from the National Library of Medicine

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


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
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