Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.

Detailed Description
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Previous studies have demonstrated the effectiveness of certain probiotic strains in the treatment of vaginal candidiasis, alone or as an adjunct to antifungal treatments, as well as the effectiveness of a Lactobacillus strain as maintenance treatment after antifungal treatment to reduce the recurrence rate of candidiasis However, to date, no studies have evaluated the oral efficacy of a probiotic strain of Lactobacillus originally isolated from breast milk in the prevention of new vaginal yeast events in women with recurrent vaginal yeast infections. The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.

Official Title
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Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis

Conditions
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Recurrent Vulvovaginal Candidiasis

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Lactobacillus strain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women from 18 to 49 years old. Having suffered at least four outbreaks of vaginal yeast infection in the last year. Signed Informed Consent Form. Agree to provide the scheduled samples. Agree to perform gynecological examinations Agree to report candidiasis events that occur during the study. Ability to complete surveys. Exclusion Criteria: Being currently consuming or having consumed a probiotic in the two weeks prior to the study. Being under antibiotic treatment at the time of beginning the study. Being under pharmacological treatment for the treatment of candidiasis. Have an allergy to an antibiotic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Volunteers will take 1 capsule per day with maltodextrin for 6 months | Dietary Supplement: Placebo<br>* Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits<br>|
| Experimental: Probiotic group<br>Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months | Dietary Supplement: Lactobacillus strain<br>* Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of candidiasis events | Total candidiasis events during intervention | 6 months | 
| Time between episodes | Days from baseline until candidiasis events | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Candida in vaginal exudate by culture analysis | Analysis of the presence of Candida in vaginal exudate | 6 months | 
| Microbiota of vaginal exudate | Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples | 6 months | 
| Gynecological examination | The gynecologist will perform a gynecological examination to check:Presence of erythema of the vulva, erythema of the vaginal mucosa, lumpy, whitish-coloured vulvar oedema and excoriation of the vulva | 6 months | 
| pH of vaginal discharge | Measurement of the pH of vaginal discharge | 6 months | 
| Test of related clinical symptoms | The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia. | 6 months | 
| Intensity of the related clinical symptoms | Intensity (mild, moderate, intense) of the related clinical symptoms | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Recurrent Vulvovaginal Candidiasis, Probiotics