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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
76
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
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
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain
Recurrence of candidiasis events
Total candidiasis events during intervention
Time frame: 6 months
Time between episodes
Days from baseline until candidiasis events
Time frame: 6 months
Determination of Candida in vaginal exudate by culture analysis
Analysis of the presence of Candida in vaginal exudate
Time frame: 6 months
Microbiota of vaginal exudate
Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
Time frame: 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
Time frame: 6 months
pH of vaginal discharge
Measurement of the pH of vaginal discharge
Time frame: 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.
Time frame: 6 months
Intensity of the related clinical symptoms
Intensity (mild, moderate, intense) of the related clinical symptoms
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months