Clinical trial NCT02859493: Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis
Official title: Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Candidiasis, Vulvovaginal
Lead sponsor: Lesaffre International
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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.

Primary outcomes:
measure: Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis
timeFrame: after 7 days and 14 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Dermscan
Study officials:
References: