Clinical trial NCT01089348: A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis
Official title: Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Bacterial Vaginosis
Keywords: Vaginosis, Bacterial
Prebiotics
Lactofiltrum
Therapy
Lead sponsor: Avva Rus, JSC
Sponsor class: INDUSTRY
Collaborators: name: Kirov State Medical Academy
name: Kirov Regional clinical Center of Perinatology
First posted: 2010-03-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Self-reported complaints
timeFrame: Days 0, 14 and 44 after start of intervention
Secondary outcomes:
measure: Gynaecological examination
timeFrame: Days 0, 14 and 44 after start of intervention
measure: Microscopy of vaginal discharge
timeFrame: Days 0, 14 and 44 after start of intervention
measure: Microbiological examination of vaginal discharge
timeFrame: Days 0, 14 and 44 after start of intervention
measure: pH-test of vaginal discharge
timeFrame: Days 0, 14 and 44 after start of intervention
measure: Microbiological feces analysis
timeFrame: Days 0, 14 and 44 after start of intervention
measure: Blood test
timeFrame: Days 0, 14 and 44 after start of intervention
measure: Urine test
timeFrame: Days 0, 14 and 44 after start of intervention
Other outcomes:
Locations:
city: Kirov
country: Russian Federation
facility: Kirov State Medical Academy
state: Kirov oblast
city: Kirov
country: Russian Federation
facility: Kirov Regional Clinical Center of Perinatology
state: Kirov oblast
Study officials:
affiliation: Avva Rus, JSC
name: Lyudmila Kobeleva, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kirov State Medical Academy
name: Sergey Dvoryanskiy, MD, DrSc
role: PRINCIPAL_INVESTIGATOR
References: