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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345096

Enrollment

Registered

2015-01-26

Start date

2015-01-31

Completion date

2016-08-31

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvo-vaginal Candidiasis

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.

Interventions

DIETARY_SUPPLEMENTSaccharomyces cerevisiae

DIETARY_SUPPLEMENTPlacebo

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 No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Enumeration of Candida albicans in a vaginal sampling	up to 2 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026