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

Lesaffre

Status: Terminated

Conditions: Vulvo-vaginal Candidiasis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Saccharomyces cerevisiae

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345096

OP090414.LES

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

22 participants in 2 patient groups, including a placebo group

Saccharomyces cerevisiae CNCM I-3856

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Saccharomyces cerevisiae

placebo

Placebo Comparator group

Description:

In this arm, subjects will be asked to consume one capsule of placebo per day.

Treatment:

Dietary Supplement: Placebo