About this trial
Introduction: Bacterial vaginosis (BV) is the most prevalent vaginal dysbiosis in women of reproductive age and is associated with adverse gynecological and obstetric outcomes; therefore, its diagnosis and appropriate treatment are of significant clinical importance. National and international guidelines recommend the treatment of bacterial vaginosis with oral or vaginal metronidazole or vaginal clindamycin. However, approximately 50% of women experience recurrence of the disease one year after treatment. Persistence of residual disease, treatment resistance, reinfection, and biofilm formation hindering the effectiveness of antimicrobial therapy are cited as causes of recurrence, although the mechanism remains uncertain. Objective: To evaluate the efficacy of using 401 ± 5 nm blue light-emitting diodes combined with metronidazole in preventing the recurrence of bacterial vaginosis, and to compare the diagnostic accuracy of bacterial vaginosis using Amsel and Nugent criteria. Methods: A randomized clinical trial will be conducted including 40 sexually active women aged 18 to 60 years with a microscopic diagnosis of bacterial vaginosis according to Nugent criteria. Participants will complete a structured questionnaire and undergo a gynecological examination including vaginal pH measurement, amine testing, and 5 collection of vaginal contents for fresh microscopic examination and Gram staining. The diagnosis will be established according to the Nugent score criteria. The group will be randomized, with 20 participants allocated to the group receiving oral metronidazole treatment and 20 participants receiving oral metronidazole treatment combined with 401 +/- 5 nm Blue Light Emitting Diode therapy, lasting 15 minutes in 8 sessions. Participants will be evaluated by a gynecologist before, 21 days after, and 3 months after treatment. Statistical analysis will be performed with a significance level of 5%. Expected results: It is expected that treatment with 401 +/- 5 nm blue LED light, combined with conventional metronidazole treatment, be effective in reducing the recurrence of bacterial vaginosis. Conclusion: The findings may contribute to the planning of future studies to evaluate the effectiveness of the treatment in reducing the recurrence of vaginosis, with a potential impact on the prevention of adverse gynecological and obstetric outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 to 60 years.
Sexually active women.
Diagnosis of bacterial vaginosis according to the Nugent scoring system.
Normal cervical cytology (Pap smear) within the previous 12 months.
Disqualifiers
Pregnancy.
Genital bleeding or sexual intercourse within 72 hours before the gynecological evaluation.
Use of oral antibiotics, antifungals, corticosteroids, or vaginal creams within the previous 30 days.
Known allergy or contraindication to metronidazole.
Trial design
Parallel
Treatments tested in this trial
Metronidazole
DrugOral metronidazole 500 mg every 12 hours for 7 consecutive days.
Blue Light-Emitting Diode (LED)
DeviceBlue light-emitting diode therapy at 401 ± 5 nm, administered in eight sessions of 15 minutes each
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of bacterial vaginosis
Occurrence of bacterial vaginosis recurrence after treatment, assessed by clinical and laboratory criteria according to the study protocol.
Locations
Sponsors and contacts
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Patricia Lordelo
Lead sponsor
Centro de Atenção ao Assoalho Pélvico
Sponsor institution
Escola Bahiana de Medicina e Saude Publica
Collaborator
This trial is not recruiting at the moment. You can still explore other options: