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

Phase 4

Completed

• Conditions: Vaginosis, Bacterial; Candidiasis
• Interventions: Device: Boric acid and probiotics; Drug: Antibiotic (Clindamycin); Drug: Antifungal (Clotrimazole)

• Registration Number: NCT02860845
• Lead Sponsor: Laboratorios Ordesa

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2016-07-12
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Primary Completion: 2017-10-16
• Study Completion: 2017-11-30
• Results First Submitted: 2019-08-19
• Results First Submitted QC: 2019-10-15
• Status Verified: 2019-11
• Results First Posted: 2019-11-04
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boric acid and probiotics	Boric acid and probiotics	Boric acid with L.gasseri and L.rhamnosus
Antibiotic/Antifungal	Antifungal (Clotrimazole)	Antibiotic: Clindamicine Antifungal: Clotrimazol
Antibiotic/Antifungal	Antibiotic (Clindamycin)	Antibiotic: Clindamicine Antifungal: Clotrimazol

Primary Outcome Measures

Name	Time	Method
Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.	Baseline and at 2 weeks after treatment finalization	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)

Secondary Outcome Measures

Name	Time	Method
Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.	Baseline and 2 weeks after treatment finalization	Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.
Number of Participants With Recurrent Infections	At 3 months after recruitment	Descriptive of the proportion of patients with vulvovaginitis recurrence

Trial Locations

Locations (1)

Ginemed Sevilla; 🇪🇸 Sevilla, Andalucía, Spain