NCT06725888

Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: S.I.I.T. Srl · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis (BV)
• Recurrent Bacterial Vaginosis

Interventions

Type	Name	Description
DEVICE	Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:	Vagitab -T will be used for 3 monthly cycles of 10 days each. Metronidazole will be used for 1 cycle of 7 days at the start of the study Metronidazole will be administered as follows: 500 mg intravaginally once per day for 7 days or 500 mg orally 2 times/day for 7 days

Timeline

• Start date: 2025-03-31
• Primary completion: 2025-09-23
• Completion: 2025-09-30
• First posted: 2024-12-10
• Last updated: 2025-05-28

Locations

1 site across 1 country: Romania