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

Primary Purpose

Bacterial Vaginosis

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Lactofiltrum + Metronidazole
Metronidazole
Sponsored by
Avva Rus, JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Vaginosis, Bacterial, Prebiotics, Lactofiltrum, Therapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kirov State Medical AcademyRecruiting
  • Kirov Regional Clinical Center of PerinatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactofiltrum

Control

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Microscopy of vaginal discharge
Microbiological examination of vaginal discharge
pH-test of vaginal discharge
Microbiological feces analysis
Blood test
Urine test

Full Information

First Posted
March 17, 2010
Last Updated
July 20, 2010
Sponsor
Avva Rus, JSC
Collaborators
Kirov State Medical Academy, Kirov Regional clinical Center of Perinatology
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1. Study Identification

Unique Protocol Identification Number
NCT01089348
Brief Title
A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis
Acronym
LF-BV-09
Official Title
Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Avva Rus, JSC
Collaborators
Kirov State Medical Academy, Kirov Regional clinical Center of Perinatology

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
Vaginosis, Bacterial, Prebiotics, Lactofiltrum, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactofiltrum
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactofiltrum + Metronidazole
Intervention Description
Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Metronidazole 500 mg 1 tablet BID for 7 days per os
Primary Outcome Measure Information:
Title
Self-reported complaints
Description
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).
Time Frame
Days 0, 14 and 44 after start of intervention
Secondary Outcome Measure Information:
Title
Gynaecological examination
Description
It's represented by three ordinal scales with minimal value "0" ("not at all") and maximal value "3" ("severe"). They are measured by physician.
Time Frame
Days 0, 14 and 44 after start of intervention
Title
Microscopy of vaginal discharge
Time Frame
Days 0, 14 and 44 after start of intervention
Title
Microbiological examination of vaginal discharge
Time Frame
Days 0, 14 and 44 after start of intervention
Title
pH-test of vaginal discharge
Time Frame
Days 0, 14 and 44 after start of intervention
Title
Microbiological feces analysis
Time Frame
Days 0, 14 and 44 after start of intervention
Title
Blood test
Time Frame
Days 0, 14 and 44 after start of intervention
Title
Urine test
Time Frame
Days 0, 14 and 44 after start of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lyudmila Kobeleva, MD, PhD
Phone
+7-495-9567559
Email
kobeleva@leksir.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Nickolay A. Kryuchkov, MD, PhD, MPH
Phone
+7-495-9567559
Email
nkryuchkov@leksir.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyudmila Kobeleva, MD, PhD
Organizational Affiliation
Avva Rus, JSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergey Dvoryanskiy, MD, DrSc
Organizational Affiliation
Kirov State Medical Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirov State Medical Academy
City
Kirov
State/Province
Kirov oblast
ZIP/Postal Code
610027
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Dvoryanskiy, MD, DrSc
Phone
+7-8332-277211
Email
dvorsa@mail.ru
First Name & Middle Initial & Last Name & Degree
Sergey Dvoryanskiy, MD, DrSc
Facility Name
Kirov Regional Clinical Center of Perinatology
City
Kirov
State/Province
Kirov oblast
ZIP/Postal Code
610048
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadezhda Yagovkina, MD, PhD
Phone
+7-8332-523639
Email
nadezhda-yagovkina@yandex.ru
First Name & Middle Initial & Last Name & Degree
Nadezhda Yagovkina, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis

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