Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
NCT Number: NCT06458543
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Bacterial Vaginosis
Interventions: DRUG: Longidaza|DRUG: Metronidazole 500 mg
Sponsor: I.M. Sechenov First Moscow State Medical University
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-06-01
Locations: LLC "Family polyclinic No. 4" Korolev, Korolev, 141060, Russian Federation|I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, 119991, Russian Federation

Summary:
The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:

* Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
* use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
* use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.

Participants in the experimental and control group will be:

* Amsel criteria assessment
* Colpotest-PH (vaginal acidity)
* aminotest with 10% KOH solution ("fish odor")
* microscopic examination of vaginal discharge
* Bacteriologic culture of vaginal discharge
* Polymerase chain reaction of epithelial cell scrapings from the vagina
* electron microscopy of vaginal epithelial cell scrapings

Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.

Participants in the control group: Metronidazole.

Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.

Primary Outcome Measures: Reduction in the number of relapses of bacterial vaginosis, Evaluated by clinical data (using Amsel criteria) and laboratory (microscopic examination - identification of "key cells")

The Amsel criteria include 4 parameters, each of which is scored as one point:

* gray/white/grayish-white vaginal discharge
* Vaginal acidity pH greater than 4.5 (colpotest pH)
* aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
* Presence of "key cell" in microscopic examination of vaginal discharge

The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis", 6 months after treatment
Secondary Outcome Measures: changes in biofilm structure according to electron microscopy data, Biofilms are a cooperation of microorganisms of one or more species that are incorporated into a polymeric matrix consisting of proteins, polysaccharides and nucleic acids. Electron microscopy allows to evaluate the structure of the biofilm, to distinguish between lactobacilli and anaerobes (G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). The destructive effect of azoximers bovgialuronidase on biofilms leads to disruption of biofilm structure: formation of holes in its structure, reduction of its size (volume), release of bacteria from the biofilm structure. Metronidazole has a bactericidal effect on G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc., which is expressed in the reduction of CFU/ml., 21 days after treatment|decrease in the severity of characteristic complaints in female patients with BV, The main complaints that patients with bacterial vaginosis present with are: vaginal discharge and unpleasant odor of vaginal discharge.

The Amsel criteria are used to objectively assess these complaints

The Amsel criteria include 4 parameters, each of which is scored as one point:

* gray/white/grayish-white vaginal discharge
* Vaginal acidity pH greater than 4.5 (colpotest pH)
* aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
* Presence of "key cell" in microscopic examination of vaginal discharge

The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"

After treatment the patient is expected to have no characteristic complaints, 21 days after treatment|Decreased vaginal acidity, Normally, the acidity of the vagina is 4.5 or less (рН=4,5 оr less), meaning the vagina has an acidic environment.

The pH is measured with the Kolpotest-PH rapid test. After applying vaginal discharge to the indicator screen of the test strip, it is colored. The color obtained is compared with the indicator scale placed on the Colpotest-pH jar. If the pH is 4.5 or less, it is normal.

A pH result greater than 4.5 favors a diagnosis of bacterial vaginosis After treatment is expected to normalize vaginal acidity (pH = 4.5 or less), 21 days after treatment|Normalization of the composition of the microflora of the urogenital tract, Normally, the vagina of women of reproductive age is dominated by Lactobacilli (80-100%). A decrease in lactobacilli or their absence leads to the dominance of opportunistic microorganisms (e.g., G.vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.), which causes the appearance of complaints characteristic of bacterial vaginosis (vaginal discharge, unpleasant odor of vaginal discharge, itching, burning).

Microbiome is assessed by polymer chain reaction (Femoflor-16), which allows not only qualitative but also quantitative assessment of the composition of the vaginal microbiome.

After treatment, the number of opportunistic anaerobes is expected to decrease and the number of lactobacilli is expected to be dominant, 21 days after treatment