Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorS.I.I.T. Srl
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
DeviceVagitab -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
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Vagitab-T plus metronidazole (the standard treatment for bacterial vaginosis).Experimental treatment 1 intervention
Trial outcomes
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).
Time frame
90 daysSecondary outcomes
1
Fluidity of vaginal secretion
The subjective rating of vaginal secretion fluidity is determined by patients using a Visual Analog Scale (VAS). The VAS is a horizontal line, 100 mm in length. The left end of the line is marked "0," indicating minimum fluidity, while the right end is marked "100," indicating maximum fluidity. Patients are instructed to mark the point on the line that best represents the fluidity of their secretions. The VAS score is determined by measuring millimeters from the left end of the line to the point marked by the patient. Change is assessed from baseline to 90 days (end of study).
Time frame
90 days2
Normality of vaginal flora
It is evaluated by the investigators using the Nugent score. The vaginal smears are plated on a microscope slide in oil immersion and at least 10 high power fields are examined for three bacterial morphotypes: Lactobacillus, Gardnerella, and curved gram rods. Each of these three categories is given a score based on the number of bacteria counted. These three scores are then added together to give a total score from 0 - 10. The score is as follows: 0-3: negative for BV, 4-6: intermediate, and 7+: positive for BV. Samples analysis is performed in a central laboratory. Change will be assessed from baseline to 90 days (end of study).
Time frame
90 days3
Vaginal Lactobacillus Microbiota
Mucus and cell samples collected from the endocervix by swabbing will be evaluated by optical microscopy using the following classification: normal (numerous pleomorphic lactobacilli, no other bacteria or clue cells or hyphae); partially impaired (population of lactobacilli severely reduced); pathological (lactobacilli severely reduced or absent due to overgrowth of other bacteria or clue cells (\>20%) or hyphae). Change evaluated from baseline to 90 days (end of study)
Time frame
90 days4
Vaginal Discharge
It is evaluated over the past 24 hours using the following 3-point scale: 0 = absent or physiological; 1 = mildly abnormal (abnormal amount with normal color and type); 2 = abnormal amount and abnormal color and type.
Time frame
90 daysSponsors and contacts
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S.I.I.T. Srl
Lead sponsor
Opera CRO, a TIGERMED Group Company
Collaborator
Source ClinicalTrials.gov