Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis

Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)

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. The administration of yeast will be local (vaginal).

Study Overview

• Status: Terminated
• Conditions: Candidiasis, Vulvovaginal
• Intervention / Treatment: Device: Placebo; Device: Saccharomyces cerevisiae

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Dermscan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subject suffering from a vulvo-vaginal candidiasis (according to clinical examination) characterized by a vaginal discharge associated with any of the following symptoms: itching and burning vaginal feeling, dyspareunia and dysuria.
• Amenorrheic subject, or subject having a regular menstrual cycle.
• Subject psychologically able to understand the study related information and to give a written informed consent.
• Subject having given freely and expressly her informed consent.
• Subject able to comply with protocol requirements, as defined in the protocol.
• Subject affiliated to a health social security system.
• Female subjects of childbearing potential should use a medically accepted contraceptive regimen (except latex condom, latex diaphragm, spermicidal) during the D0-D14 period, since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end, at the investigator's discretion

Exclusion Criteria:

In terms of population

• Pregnant or nursing woman or planning a pregnancy during the study.
• Post-menopausal women.
• Subject who will have her period between the first and the second visit to the gynaecologist (between D0 and D7).
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• Subject suspected to be non-compliant according to the investigator's judgment.
• Subject enrolled in another clinical trial on the same test zone within the four previous weeks and during the study period, being in an exclusion period for a previous study, having tested a food supplement or a medication in the 4 previous weeks.
• Subject in an emergency situation. In terms of associated pathology
• Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
• Subject suffering from systemic diseases using concurrent therapy that may interfere with the evaluation of the study results.
• Subject with a known allergy to one of the component of the study products or to the medication (vaginal ovule and/or antifungal cream).
• Subject presenting an hypersensitivity to any antifungal of imidazole family or to one of the excipient.
• Uterine or vaginal bleeding of unknown origin
• Subject with known sexually transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus or HIV 1 or 2.
• Immunocompromised subjects

Relating to previous or ongoing treatment

• Subject undergoing a topical treatment on the test area or a systemic or intravaginal treatment:

• antibiotics currently or within the past 2 weeks (systemic antibiotic are accepted if the treatment was stopped until the day before the inclusion visit)
• anti-fungal agents currently or within the past 2 weeks,
• anticoagulant within the past 2 weeks and during the study,
• anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study,
• corticosteroids during the 2 previous weeks and during the study,
• retinoids and/or immunosuppressors during the 3 previous months and during the study,
• any medication stabilized for less than one month.

In terms of lifestyle

• Subject planning to change her usual hygiene habits and products during the study.
• Subjects not willing to stop taking probiotics dietary supplements and food products enriched with probiotics.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Saccharomyces cerevisiae; Inactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days.	Device: Saccharomyces cerevisiae
Placebo Comparator: Maize starch and magnesium stearate; Placebo presented in a vaginal capsule. 1 capsule a day for 14 days	Device: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis	valuation of the effect of vaginal administration of Saccharomyces cerevisiae on the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis, by counting Candida spp in vaginal samples, before treatment and after 7 days and 14 days of treatment, in addition to a conventional medical treatment and in comparison to the placebo product.	after 7 days and 14 days of treatment

Collaborators and Investigators

• Sponsor: Lesaffre International

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: 15E2899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No