Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

Conditions
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Vulvo-vaginal Candidiasis

Intervention / Treatment
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* Dietary Supplement: Saccharomyces cerevisiae
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis Regularly menstruating women with normal gynaecological status Patient must use a contraception method Having given a written informed consent prior to selection Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Exclusion Criteria: Pregnancy or breast feeding. Tumors in the genital tract or beast. Hypersensitivity to the study product. Uterine or vaginal bleeding of unknown origin. Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days. Concomitant medication with antimycotics for other diagnoses. Woman with known transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus, HIV 1 or 2. Immunocompromised individuals. Subjects not willing to stop taking probiotics in the form of dietary supplements or convenient goods Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development. Subject under administrative or legal supervision. Subject who participate to a previous study within 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saccharomyces cerevisiae CNCM I-3856<br>In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day. | Dietary Supplement: Saccharomyces cerevisiae<br> <br> |
| Placebo Comparator: placebo<br>In this arm, subjects will be asked to consume one capsule of placebo per day. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enumeration of Candida albicans in a vaginal sampling |  | up to 2 months |