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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 October 23, 2014