A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis (LF-BV-09)

Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis

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.

Study Overview

• Status: Unknown
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Lactofiltrum + Metronidazole; Drug: Metronidazole

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Kirov oblast
    • Kirov, Kirov oblast, Russian Federation, 610027
      • Recruiting
      • Kirov State Medical Academy
      • Contact: Sergey Dvoryanskiy, MD, DrSc; Phone Number: +7-8332-277211; Email: dvorsa@mail.ru
      • Principal Investigator: Sergey Dvoryanskiy, MD, DrSc
    • Kirov, Kirov oblast, Russian Federation, 610048
      • Recruiting
      • Kirov Regional Clinical Center of Perinatology
      • Contact: Nadezhda Yagovkina, MD, PhD; Phone Number: +7-8332-523639; Email: nadezhda-yagovkina@yandex.ru
      • Principal Investigator: Nadezhda Yagovkina, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control	Drug: Metronidazole; Metronidazole 500 mg 1 tablet BID for 7 days per os
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported complaints	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).	Days 0, 14 and 44 after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gynaecological examination	It's represented by three ordinal scales with minimal value "0" ("not at all") and maximal value "3" ("severe"). They are measured by physician.	Days 0, 14 and 44 after start of intervention
Microscopy of vaginal discharge		Days 0, 14 and 44 after start of intervention
Microbiological examination of vaginal discharge		Days 0, 14 and 44 after start of intervention
pH-test of vaginal discharge		Days 0, 14 and 44 after start of intervention
Microbiological feces analysis		Days 0, 14 and 44 after start of intervention
Blood test		Days 0, 14 and 44 after start of intervention
Urine test		Days 0, 14 and 44 after start of intervention

Collaborators and Investigators

• Sponsor: Avva Rus, JSC
• Collaborators: Kirov State Medical Academy; Kirov Regional clinical Center of Perinatology
• Investigators: Principal Investigator: Sergey Dvoryanskiy, MD, DrSc, Kirov State Medical Academy

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ANTICIPATED): October 1, 2010
• Study Completion (ANTICIPATED): December 1, 2010

Study Registration Dates

• First Submitted: March 17, 2010
• First Submitted That Met QC Criteria: March 17, 2010
• First Posted (ESTIMATE): March 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 21, 2010
• Last Update Submitted That Met QC Criteria: July 20, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Therapy; Prebiotics; Lactofiltrum; Vaginosis, Bacterial
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 02/09-AVVA RUS