Bacterial VaginosisNCT07835815
Photobiomodulation With Blue LED in Recurrent Bacterial Vaginosis
A study testing Metronidazole and Blue Light-Emitting Diode (LED) in people with Bacterial Vaginosis, run by Patricia Lordelo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Metronidazole and Blue Light-Emitting Diode (LED)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bacterial Vaginosis
- Being tested
- Metronidazole, Blue Light-Emitting Diode (LED)
- Keywords
- bacterial vaginosis, bacterial vaginosis recurrence, phototherapy, Nugent score, women's health
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Oral metronidazole 500 mg every 12 hours for 7 consecutive days.
Blue Light-Emitting Diode (LED)Device
Also called Blue LED Group
Blue light-emitting diode therapy at 401 ± 5 nm, administered in eight sessions of 15 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days. Receives: Drug: Metronidazole |
| Experimental Group - Blue LED | Experimental | 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. Receives: Drug: Metronidazole; Device: Blue Light-Emitting Diode (LED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of bacterial vaginosis
Occurrence of bacterial vaginosis recurrence after treatment, assessed by clinical and laboratory criteria according to the study protocol.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The control group will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days. The intervention group will receive the same oral metronidazole regimen combined with eight sessions of blue light-emitting diode (LED) therapy at 401 ± 5 nm. Participants will remain in their assigned group throughout the study and will be followed for the occurrence of bacterial vaginosis recurrence.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricia Lordelo
- Sponsor type
- University, hospital or other
- Collaborators
- Escola Bahiana de Medicina e Saude Publica
- Responsible party
- Sponsor-investigator, Patricia Lordelo, Centro de Atenção ao Assoalho Pélvico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835815
- Sponsor's protocol ID
- CAAE - 00288926.3.0000.5544
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 401 ± 5 nm Blue Light-Emitting Diode in the Prevention of Recurrent Bacterial Vaginosis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07835815
- Acronym / sponsor ID
- CAAE - 00288926.3.0000.5544
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, bacterial vaginosis recurrence, phototherapy, Nugent score, women's health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Patricia LordeloUniversity, hospital or other
- Collaborators
- Escola Bahiana de Medicina e Saude Publica
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The control group will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days. The intervention group will receive the same oral metronidazole regimen combined with eight sessions of blue light-emitting diode (LED) therapy at 401 ± 5 nm. Participants will remain in their assigned group throughout the study and will be followed for the occurrence of bacterial vaginosis recurrence.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: MetronidazoleParticipants will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days. |
| Experimental Group - Blue LED | Experimental | Drug: Metronidazole, Device: Blue Light-Emitting Diode (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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleOral metronidazole 500 mg every 12 hours for 7 consecutive days. | Drug | Control Group, Experimental Group - Blue LED |
| Blue Light-Emitting Diode (LED)Also: Blue LED GroupBlue light-emitting diode therapy at 401 ± 5 nm, administered in eight sessions of 15 minutes each | Device | Experimental Group - Blue LED |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole and Blue Light-Emitting Diode (LED) in people with Bacterial Vaginosis, run by Patricia Lordelo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Silva Lordelo ((+ 55 71)996961584, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of bacterial vaginosis (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.