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

NCT01089348 | Unknown Phase 2 DMC

• 1 other identifier: 02/09-AVVA RUS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Bacterial Vaginosis

Keywords

Vaginosis, Bacterial; Prebiotics; Lactofiltrum; Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Gynaecological examination

  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

Study Arms (2)

Lactofiltrum

EXPERIMENTAL

Drug: Lactofiltrum + Metronidazole

Control

ACTIVE COMPARATOR

Drug: Metronidazole

Interventions

Lactofiltrum + Metronidazole DRUG

Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os

Lactofiltrum

Metronidazole DRUG

Metronidazole 500 mg 1 tablet BID for 7 days per os

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• bacterial vaginosis.

You may not qualify if:

• pregnancy and breast-feeding;
• concomitant infection diseases;
• application of intravaginal medicines during participation in the study;
• severe diseases;
• renal and hepatic failure;

Sponsors & Collaborators

• Avva Rus, JSC: lead
• Kirov State Medical Academy: collaborator
• Kirov Regional clinical Center of Perinatology: collaborator

Study Sites (2)

Kirov State Medical Academy

Kirov, Kirov Oblast, 610027, Russia

RECRUITING

Kirov Regional Clinical Center of Perinatology

Kirov, Kirov Oblast, 610048, Russia

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lyudmila Kobeleva, MD, PhD

  Avva Rus, JSC

  STUDY DIRECTOR

• Sergey Dvoryanskiy, MD, DrSc

  Kirov State Medical Academy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyudmila Kobeleva, MD, PhD

CONTACT

+7-495-9567559; kobeleva@leksir.ru

Nickolay A. Kryuchkov, MD, PhD, MPH

CONTACT

+7-495-9567559; nkryuchkov@leksir.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 21, 2010

Record last verified: 2010-07

Locations

RU (2)