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

Bacterial Vaginosis Clinical Trial

— LF-BV-09  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01089348
• Other study ID #: 02/09-AVVA RUS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 17, 2010
• Last updated: July 20, 2010
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: Avva Rus, JSC
• Contact: Lyudmila Kobeleva, MD, PhD
• Phone: +7-495-9567559
• Email: kobeleva[@]leksir.ru
• Is FDA regulated: No
• Health authority: Russia: Local Ethics Committee of Kirov State Medical AcademyRussia: Local Ethics Committee of Kirov Regional clinical Center of PerinatologyRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Federal Service on surveillance in Healthcare and Social development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Kirov Regional Clinical Center of Perinatology	Kirov	Kirov oblast
Russian Federation	Kirov State Medical Academy	Kirov	Kirov oblast

Sponsors (3)

Lead Sponsor	Collaborator
Avva Rus, JSC	Kirov Regional clinical Center of Perinatology, Kirov State Medical Academy

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Microscopy of vaginal discharge		Days 0, 14 and 44 after start of intervention	No
Secondary	Microbiological examination of vaginal discharge		Days 0, 14 and 44 after start of intervention	No
Secondary	pH-test of vaginal discharge		Days 0, 14 and 44 after start of intervention	No
Secondary	Microbiological feces analysis		Days 0, 14 and 44 after start of intervention	No
Secondary	Blood test		Days 0, 14 and 44 after start of intervention	Yes
Secondary	Urine test		Days 0, 14 and 44 after start of intervention	Yes