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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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