Candidiasis, Vulvovaginal
Conditions
Brief 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).
Interventions
DEVICESaccharomyces cerevisiae
DEVICEPlacebo
Sponsors
Lesaffre International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis | after 7 days and 14 days of treatment | valuation of the effect of vaginal administration of Saccharomyces cerevisiae on the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis, by counting Candida spp in vaginal samples, before treatment and after 7 days and 14 days of treatment, in addition to a conventional medical treatment and in comparison to the placebo product. |
Countries
France
Outcome results
None listed