effect of saccharomyces cerevisiae on vulvo-vaginal candidiasis

Conditions: Candidiasis, Vulvovaginal

Summary: this study aims to evaluate the effect of a specific strain of saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. this is a randomized, double-blind, placebo-controlled study. the administration of yeast will be local (vaginal).


Eligibility criteria:
inclusion criteria: * subject suffering from a vulvo-vaginal candidiasis (according to clinical examination) characterized by a vaginal discharge associated with any of the following symptoms: itching and burning vaginal feeling, dyspareunia and dysuria. * amenorrheic subject, or subject having a regular menstrual cycle. * subject psychologically able to understand the study related information and to give a written informed consent. * subject having given freely and expressly her informed consent. * subject able to comply with protocol requirements, as defined in the protocol. * subject affiliated to a health social security system. * female subjects of childbearing potential should use a medically accepted contraceptive regimen (except latex condom, latex diaphragm, spermicidal) during the d0-d14 period, since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end, at the investigator's discretion exclusion criteria: in terms of population * pregnant or nursing woman or planning a pregnancy during the study. * post-menopausal women. * subject who will have her period between the first and the second visit to the gynaecologist (between d0 and d7). * subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. * subject in a social or sanitary establishment. * subject suspected to be non-compliant according to the investigator's judgment. * subject enrolled in another clinical trial on the same test zone within the four previous weeks and during the study period, being in an exclusion period for a previous study, having tested a food supplement or a medication in the 4 previous weeks. * subject in an emergency situation. in terms of associated pathology * subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk. * subject suffering from systemic diseases using concurrent therapy that may interfere with the evaluation of the study results. * subject with a known allergy to one of the component of the study products or to the medication (vaginal ovule and/or antifungal cream). * subject presenting an hypersensitivity to any antifungal of imidazole family or to one of the excipient. * uterine or vaginal bleeding of unknown origin * subject with known sexually transmitted infections such as neisseria gonorrhoea, chlamydia trachomatis, treponema pallidum, herpes simplex, trichomonas vaginalis, human papilloma virus or hiv 1 or 2. * immunocompromised subjects relating to previous or ongoing treatment • subject undergoing a topical treatment on the test area or a systemic or intravaginal treatment: * antibiotics currently or within the past 2 weeks (systemic antibiotic are accepted if the treatment was stopped until the day before the inclusion visit) * anti-fungal agents currently or within the past 2 weeks, * anticoagulant within the past 2 weeks and during the study, * anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study, * corticosteroids during the 2 previous weeks and during the study, * retinoids and/or immunosuppressors during the 3 previous months and during the study, * any medication stabilized for less than one month. in terms of lifestyle * subject planning to change her usual hygiene habits and products during the study. * subjects not willing to stop taking probiotics dietary supplements and food products enriched with probiotics.