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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis

Conditions
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Candidiasis, Vaginosis, Bacterial

Intervention / Treatment
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* Device: Boric acid and probiotics
* Drug: Antibiotic (Clindamycin)
* Drug: Antifungal (Clotrimazole)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boric acid and probiotics<br>Boric acid with L.gasseri and L.rhamnosus | Device: Boric acid and probiotics<br>* Vaginal capsules administered once a day during 7 days.<br>|
| Active Comparator: Antibiotic/Antifungal<br>Antibiotic: Clindamicine Antifungal: Clotrimazol | Drug: Antibiotic (Clindamycin)<br>* Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.<br>* Other names: Clindamycin;Drug: Antifungal (Clotrimazole)<br>* Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.<br>* Other names: Clotrimazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and at 2 weeks after treatment finalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks after treatment finalization | 
| Number of Participants With Recurrent Infections | Descriptive of the proportion of patients with vulvovaginitis recurrence | At 3 months after recruitment |