Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- Dietary Supplement: Lactobacillus strainDietary Supplement: Placebo
- Registration Number
- NCT04639544
- Lead Sponsor
- Biosearch S.A.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 76
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic group Lactobacillus strain Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months Control group Placebo Volunteers will take 1 capsule per day with maltodextrin for 6 months
- Primary Outcome Measures
Name Time Method Recurrence of candidiasis events 6 months Total candidiasis events during intervention
Time between episodes 6 months Days from baseline until candidiasis events
- Secondary Outcome Measures
Name Time Method Microbiota of vaginal exudate 6 months Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
Gynecological examination 6 months 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
pH of vaginal discharge 6 months Measurement of the pH of vaginal discharge
Determination of Candida in vaginal exudate by culture analysis 6 months Analysis of the presence of Candida in vaginal exudate
Test of related clinical symptoms 6 months The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia.
Intensity of the related clinical symptoms 6 months Intensity (mild, moderate, intense) of the related clinical symptoms
Trial Locations
- Locations (1)
Hospital Universitario Infanta Elena
🇪🇸Valdemoro, Madrid, Spain