Phase 4 N=48 Randomized Treatment

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

Candidiasis · Vaginosis, Bacterial

Bottom Line

View on ClinicalTrials.gov: NCT02860845 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. — 1.13; 1.21; 0.18; 0.22 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Boric acid and probiotics (Device); Antibiotic (Clindamycin) (Drug); Antifungal (Clotrimazole) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Laboratorios Ordesa
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.	1.13; 1.21; 0.18; 0.22; 1.63; 1.58	—
SECONDARY Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.	51.59; 49.30; 81.82; 66.09	—
SECONDARY Number of Participants With Recurrent Infections	17; 14; 5; 9	—

Summary

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).

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02860845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.