Clinical trial NCT06725888: Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
Official title: A Prospective, Multicentre, Open-label, Study to Assess Performance and Safety of the Medical Device Vagitab - T in Rebalancing the Altered Vaginal Flora as Adjuvant Therapy in Patients With Bacterial Vaginosis and in Reducing Incidence of Recurrence During a 3-months Period of Follow-up.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis (BV)
Recurrent Bacterial Vaginosis
Keywords: Bacterial Vaginosis
Recurrent Bacterial Vaginosis
Vaginal microflora
Lactobacillus
Lead sponsor: S.I.I.T. Srl
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2024-12-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.

The main goals of this trial are to see if the recurrence rate of bacterial vaginosis goes down during the study, if it helps balance the altered vaginal flora during antibiotic treatment, if it improves vaginal secretions, and if vaginal microflora return to normal. We'll also ask the participants about their quality of life and whether they think the treatment is safe.

All 30 women will get the same treatment, and there's no comparison group. They'll be treated with Vagitab-T vaginal tablets for three monthly cycles. Also, metronidazole will be taken at the start of the study for seven days.

Participants will sign an informed written consent and we'll visit them at the start (day 0) and end (day 90) of the study. In addition, we'll call them during each of the three cycles of treatment.

Detailed description: Bacterial vaginosis (BV) affects 20-25% of the general population and is the most common cause of vaginal discharge. It is a polymicrobial disease that typically manifests when the protective antibacterial activity of vaginal lactobacilli is impaired, allowing for the overgrowth of anaerobic bacteria and other pathogens, including Gardnerella vaginalis and Mycoplasma hominis. The term "recurrent bacterial vaginosis" (RBV) is used to describe a condition characterized by two to three episodes of bacterial vaginosis (BV) per year. The recurrence rates are as high as 35% within one month, 50% within three months, and 70% within 12 months.

Given the multiplicity of potential risk factors, the aetiology and pathogenesis of BV remain incompletely understood, and the efficacy of current treatment regimens is variable, resulting in high recurrence rates.

A review of the medical literature reveals that no recommended gold-standard therapies have been established, and that the treatments are not always effective, resulting in high recurrence rates. Consequently, the objective of clinical research is to identify safe and effective products that do not disrupt the delicate equilibrium of the vaginal microbiota. It is imperative to commence treatment promptly following antibiotic therapy to impede the formation of a vaginal biofilm.

Recent published reviews and meta-analyses have demonstrated the efficacy of probiotic preparations in the treatment and prevention of BV. These studies suggest that the amount of exogenously applied Lactobacilli may influence the effectiveness of the treatment. The rationale for testing Vagitab-T as an adjuvant product in the treatment of BV and in preventing the recurrences, and consequently in reducing the use of antibiotics without causing resistance, is based primarily on the synergistic association of functional ingredients and mechanism of action. Vagitab-T is a topical intravaginal tablet formulation that employs several components, including tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350, employed for the prevention and treatment of vaginal infections of bacterial or mycotic origin, for the facilitation of the regrowth of a healthy microflora, and for the reduction of the symptoms of vaginal dryness. Vagitab-T is classified as a medical device due to the mechanisms of action, which do not involve the use of biocidal, immunostimulant, or pharmacological effects. Additionally, these mechanisms do not interfere with the functions of host cells.

This open, non-randomized trial will be conducted at two clinical sites in Romania. The objective is to evaluate the efficacy, safety, and tolerability of Vagitab-T vaginal tablets in women diagnosed with bacterial vaginosis (BV) according to the Amsel criteria and with a history of recurrent BV (RBV), defined as at least two episodes per year. The patients will be treated with Vagitab-T vaginal tablets for three monthly cycles of 10 days each, with concurrent administration of metronidazole for seven days. The study duration for each patient is 90 days. The sample size has been determined to be 30 evaluable patients, and the investigators intend to screen 33 patients to achieve this number (allowing for three screening failures). The main objectives of the study will be the evaluation of the reduction of recurrence rate of Bacterial Vaginosis during a 3-month cycle treatment, the adjuvant activity in rebalancing the altered vaginal flora during the antibiotic treatment period, and in improving the fluidity of vaginal secretions. Additional objectives will be the evaluation of the rate of return to normality of vaginal microflora, the quality of life, and the safety evaluation.

Eligibility criteria: Inclusion Criteria:

* Female patients aged from 18 to 65 years (inclusive).
* Patients affected at enrolment by BV diagnosed according to Amsel criteria, candidate to start an antibiotic therapy with metronidazole.
* Patient with a medical history of RBV (at least 2 episodes of BV in the last 12 months including the current episode).
* Patients who are, in the opinion of the Investigator, able to understand the study, cooperate with the study procedures and attend all the study visits.
* Patients who have given their written informed consent to participate in the study.

Exclusion Criteria:

* Patient with a medical history of HIV or any other immunodeficiency.
* Patients working as sex workers.
* Patients with known allergies or intolerance / hypersensitivity to the tested medical device and its components.
* Patients with concomitant menstrual bleeding at baseline.
* Time between the last day of last menses and treatment with metronidazole ≤ 3 days.
* Pregnant, lactating, and lactating amenorrhoeic patients and patients of childbearing potential who are planning a pregnancy or unwilling to use appropriate methods of contraception during the study
* Concomitant use of vaginal tampons.
* Concomitant administration of etonogestrel/ethinyl estradiol vaginal rings or of intrauterine devices.
* Concomitant use of oral or vaginal antibiotic therapy (apart from metronidazole) or any other vaginal therapies or treatment (such as douching, spermicide).
* Concomitant use of oral or vaginal probiotics.
* Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalization during the study.
* Concomitant or previous (in the previous 30 days) participation in any other interventional clinical trials

Primary outcomes:
measure: Bacterial Vaginosis (BV) Recurrence
timeFrame: 90 days
Secondary outcomes:
measure: Fluidity of vaginal secretion
timeFrame: 90 days
measure: Normality of vaginal flora
timeFrame: 90 days
measure: Vaginal Lactobacillus Microbiota
timeFrame: 90 days
measure: Vaginal Discharge
timeFrame: 90 days
measure: Burning
timeFrame: 90 days
measure: Erythema
timeFrame: 90 days
measure: Dyspareunia
timeFrame: 90 days
measure: Quality of Life (QoL)
timeFrame: 90 days
measure: Investigator Overall Performance
timeFrame: 90 days
measure: Patient Overall Performance
timeFrame: 90 days
measure: Investigator Overall Safety
timeFrame: 90 days
measure: Patient Overall Safety
timeFrame: 90 days
measure: Serious Adverse Device Effects / Serious Adverse Events /Adverse Device Effects/ Adverse Events
timeFrame: 90 days
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2
state: Timis
Study officials:
affiliation: Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 - Timisoara (Romania)
name: Attila Fogarassy, MD
role: PRINCIPAL_INVESTIGATOR
References: