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

NCT06725888 | Recruiting

• 1 other identifier: SIIT/VAG/0222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis (BV); Recurrent Bacterial Vaginosis

Keywords

Bacterial Vaginosis; Recurrent Bacterial Vaginosis; Vaginal microflora; Lactobacillus

Outcome Measures

Primary Outcomes (1)

• Bacterial Vaginosis (BV) Recurrence

  BV recurrences will be clinically diagnosed according to the Amsel criteria, which define the presence of BV based on the presence of at least 3 of the following 4 criteria: vaginal pH \> 4.5, clue cells on saline wet mount, release of a fishy amine odor when 10% potassium hydroxide is added to a drop of vaginal discharge ("whiff test"), and/or characteristic thin, homogeneous vaginal discharge. The number of BV recurrences in the enrolled population during the 3 months of the study will be compared to the average untreated recurrence rate reported in the medical literature (approximately 50% within 3 months).

  90 days

Secondary Outcomes (13)

• Fluidity of vaginal secretion

  90 days

• Normality of vaginal flora

  90 days

• Vaginal Lactobacillus Microbiota

  90 days

• Vaginal Discharge

  90 days

• Burning

  90 days

Study Arms (1)

Vagitab-T plus metronidazole (the standard treatment for bacterial vaginosis).

EXPERIMENTAL

Vagitab-T for 3 monthly cycles In addition, metronidazole (the standard treatment for bacterial vaginosis) will be administered for seven days. Vagitab -T: 1.1 g vaginal tablets; medical device class IIa, already CE marked. The product contains the following components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350 Metronidazole It is the treatment indicated for Bacterial Vaginosis by the 2021 CDC's Sexually Transmitted Infections Treatment Guidelines. Metronidazole will be administered vaginally (as 500 mg vaginal ovules) or orally (as 500 mg tablets)

Device: Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:

Interventions

Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350: DEVICE

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

Vagitab-T plus metronidazole (the standard treatment for bacterial vaginosis).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female will be included in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• S.I.I.T. Srl: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2

Timișoara, Timiș County, 300006, Romania

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Attila Fogarassy, MD

  Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 - Timisoara (Romania)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Montarolo, MD

CONTACT

+39 02484352278; f.montarolo@siit-it.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 10, 2024
• Study Start: March 31, 2025
• Primary Completion: September 23, 2025
• Study Completion: September 30, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

RO (1)