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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2010 by Avva Rus, JSC.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01089348

First Posted: March 18, 2010

Last Update Posted: July 21, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Kirov State Medical Academy

Kirov Regional clinical Center of Perinatology

Information provided by:

Avva Rus, JSC

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 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

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Diseases

Drug Information available for: Metronidazole Metronidazole hydrochloride

U.S. FDA Resources

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 ]
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 ]
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 ]
Microbiological examination of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
pH-test of vaginal discharge [ Time Frame: Days 0, 14 and 44 after start of intervention ]
Microbiological feces analysis [ Time Frame: Days 0, 14 and 44 after start of intervention ]
Blood test [ Time Frame: Days 0, 14 and 44 after start of intervention ]
Urine test [ Time Frame: Days 0, 14 and 44 after start of intervention ]


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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


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 Submitted:	March 17, 2010
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

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