Vulvo-vaginal Candidiasis Clinical Trial
Official title:
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
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.
| Status | Terminated |
| Enrollment | 22 |
| Est. completion date | August 2016 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| France | Eurofins Optimed | Gières |
| Lead Sponsor | Collaborator |
|---|---|
| Lesaffre International | Eurofins Optimed |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Enumeration of Candida albicans in a vaginal sampling | up to 2 months | No |