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

Laboratorios Ordesa48 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Candidiasis Vaginosis, Bacterial

Interventions

Boric acid and probioticsDEVICE

Vaginal capsules administered once a day during 7 days.

Antibiotic (Clindamycin)DRUG

Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.

Antifungal (Clotrimazole)DRUG

Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ginemed Sevilla

Seville, Andalusia, Spain

Outcomes

Primary Outcomes

Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.

Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe)

Time frame: Baseline and at 2 weeks after treatment finalization

Secondary Outcomes

Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.

Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.

Time frame: Baseline and 2 weeks after treatment finalization

Number of Participants With Recurrent Infections

Descriptive of the proportion of patients with vulvovaginitis recurrence

Time frame: At 3 months after recruitment

Data from ClinicalTrials.gov

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