Photobiomodulation With Blue LED in Recurrent Bacterial Vaginosis

NCT07835815 | Not Yet Recruiting FDA Device

• 1 other identifier: CAAE - 00288926.3.0000.5544
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosis; bacterial vaginosis recurrence; phototherapy; Nugent score; women's health

Outcome Measures

Primary Outcomes (1)

• Recurrence of bacterial vaginosis

  Occurrence of bacterial vaginosis recurrence after treatment, assessed by clinical and laboratory criteria according to the study protocol.

  3 months after treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants will receive oral metronidazole 500 mg every 12 hours for 7 consecutive days.

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.

Drug: Metronidazole; Device: Blue Light-Emitting Diode (LED)

Interventions

Metronidazole DRUG

Oral metronidazole 500 mg every 12 hours for 7 consecutive days.

Control Group; Experimental Group - Blue LED

Blue Light-Emitting Diode (LED) DEVICE

Blue light-emitting diode therapy at 401 ± 5 nm, administered in eight sessions of 15 minutes each

Also known as: Blue LED Group

Experimental Group - Blue LED

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patricia Lordelo: lead
• Escola Bahiana de Medicina e Saude Publica: collaborator

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Patricia Silva Lordelo

CONTACT

(+ 55 71)996961584; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share