Clinical Research Directory

Photobiomodulation With Blue LED in Recurrent Bacterial Vaginosis

Sponsor: Patricia Lordelo

Summary

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.

Official title: Use of 401 ± 5 nm Blue Light-Emitting Diode in the Prevention of Recurrent Bacterial Vaginosis: A Randomized Clinical Trial

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