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

Not Applicable

Terminated

• Conditions: Vulvo-vaginal Candidiasis
• Interventions: Dietary Supplement: Saccharomyces cerevisiae; Dietary Supplement: Placebo

• Registration Number: NCT02345096
• Lead Sponsor: Lesaffre International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Primary Completion: 2015-06
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saccharomyces cerevisiae CNCM I-3856	Saccharomyces cerevisiae	In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.
placebo	Placebo	In this arm, subjects will be asked to consume one capsule of placebo per day.

Primary Outcome Measures

Name	Time	Method
Enumeration of Candida albicans in a vaginal sampling	up to 2 months

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gières, France