Recurrent Vulvovaginal Candidiasis
Conditions
Keywords
Recurrent Vulvovaginal Candidiasis, Prevention, Probiotics
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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
DIETARY_SUPPLEMENTLactobacillus strain
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
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy women from 18 to 49 years old. 2. Having suffered at least four outbreaks of vaginal yeast infection in the last year. 3. Signed Informed Consent Form. 4. Agree to provide the scheduled samples. 5. Agree to perform gynecological examinations 6. Agree to report candidiasis events that occur during the study. 7. Ability to complete surveys.
Exclusion criteria
1. Being currently consuming or having consumed a probiotic in the two weeks prior to the study. 2. Being under antibiotic treatment at the time of beginning the study. 3. Being under pharmacological treatment for the treatment of candidiasis. 4. Have an allergy to an antibiotic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of candidiasis events | 6 months | Total candidiasis events during intervention |
| Time between episodes | 6 months | Days from baseline until candidiasis events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Intensity of the related clinical symptoms | 6 months | Intensity (mild, moderate, intense) of the related clinical symptoms |
| 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. |
| Microbiota of vaginal exudate | 6 months | Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples |
Countries
Spain
Contacts
Primary ContactJose Maldonado Lobón, PhD
Outcome results
None listed