Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections (DOBO)

Laboratorios Ordesa

Status and phase

Completed

Phase 4

Conditions

Vaginosis, Bacterial

Candidiasis

Treatments

Device: Boric acid and probiotics

Drug: Antibiotic (Clindamycin)

Drug: Antifungal (Clotrimazole)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02860845

DOBO-01-16

Details and patient eligibility

About

The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).

Full description

Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age over 18 years and agreement to participate by signing the consent form.
Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge).

Exclusion criteria

Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection.
Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study.
Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up.
Pregnant or high risk for pregnancy.