Photobiomodulation With Blue LED in Recurrent Bacterial Vaginosis
Use of 401 ± 5 nm Blue Light-Emitting Diode in the Prevention of Recurrent Bacterial Vaginosis: A Randomized Clinical 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bacterial vaginosis (BV) is the most prevalent vaginal dysbiosis among women of reproductive age and is associated with several adverse gynecological and obstetric outcomes. Although effective antimicrobial treatments are available, recurrence remains frequent, with recurrence rates exceeding 50% within 12 months after treatment. The pathophysiology of BV involves disruption of the normal Lactobacillus-dominated vaginal microbiota and proliferation of anaerobic and facultative anaerobic bacteria, including Gardnerella vaginalis, Fannyhessea vaginae, Mobiluncus spp., Prevotella spp., and other bacterial taxa. These microorganisms may form polymicrobial biofilms on the vaginal epithelium, which can contribute to persistence of the condition and recurrence after antimicrobial treatment. Metronidazole is an established treatment for bacterial vaginosis. However, the high recurrence rate following conventional treatment highlights the need for complementary therapeutic approaches. Blue light has demonstrated antibacterial activity in previous experimental studies. One proposed mechanism involves the excitation of endogenous microbial photosensitizing chromophores, such as porphyrins and flavins, resulting in the production of reactive oxygen species that may exert cytotoxic effects on microorganisms. Previous clinical research has also investigated the safety of 401 ± 5 nm blue LED therapy on healthy vaginal mucosa. This randomized clinical trial will investigate whether the addition of 401 ± 5 nm blue light-emitting diode (LED) photobiomodulation to conventional oral metronidazole therapy can reduce the recurrence of bacterial vaginosis compared with oral metronidazole alone. The study will also assess the diagnostic performance of the Amsel and Nugent criteria for bacterial vaginosis. Clinical and laboratory assessments will be performed during the study according to standardized procedures, including gynecological examination, vaginal pH measurement, amine testing, fresh microscopy, and Gram staining. Participants diagnosed with bacterial vaginosis will receive standard oral metronidazole treatment. Participants allocated to the intervention group will additionally undergo eight sessions of blue LED therapy. The LED treatment will be administered at the study site by a trained professional using the study-specific device. Participants will be followed after treatment to assess clinical and laboratory findings and the occurrence of recurrent bacterial vaginosis. Statistical analyses will be performed according to the prespecified study protocol, using a significance level of 5%. The study is intended to provide preliminary clinical evidence regarding the potential role of blue LED photobiomodulation as an adjunct to conventional antimicrobial therapy for reducing bacterial vaginosis recurrence. The findings may support the development of larger randomized clinical trials evaluating this complementary therapeutic approach.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Silva Lordelo
- Phone Number: (+ 55 71)996961584
- Email: pvslordelo@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Willingness to participate in the study and ability to provide written informed consent.
Exclusion Criteria:
- 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.
- Presence of genital neoplasia or suspected neoplasia.
- Presence of a pacemaker or other relevant implanted electronic device.
- Cognitive impairment or neurological or psychiatric conditions that may interfere with study participation or adherence to the protocol.
- Any other condition that, according to the investigator, may interfere with the safety of the participant or the validity of the study results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Participants will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days. |
Oral metronidazole 500 mg every 12 hours for 7 consecutive days. |
|
Experimental: Experimental Group - Blue LED
Participants will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days combined with eight sessions of blue light-emitting diode (LED) therapy at 401 ± 5 nm. |
Oral metronidazole 500 mg every 12 hours for 7 consecutive days. Blue light-emitting diode therapy at 401 ± 5 nm, administered in eight sessions of 15 minutes each
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence of bacterial vaginosis
Time Frame: 3 months after treatment
|
Occurrence of bacterial vaginosis recurrence after treatment, assessed by clinical and laboratory criteria according to the study protocol. |
3 months after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Infections
- Genital Diseases, Female
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Vaginal Diseases
- Vaginosis, Bacterial
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Imidazoles
- Nitroimidazoles
- Nitro Compounds
- Metronidazole
Other Study ID Numbers
- CAAE - 00288926.3.0000.5544
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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