Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis

NCT ID: NCT02859493

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31

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

Conditions

Candidiasis, Vulvovaginal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Saccharomyces cerevisiae

Inactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days.

Group Type: ACTIVE_COMPARATOR

Saccharomyces cerevisiae

Intervention Type: DEVICE

Maize starch and magnesium stearate

Placebo presented in a vaginal capsule. 1 capsule a day for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Interventions

Saccharomyces cerevisiae

Intervention Type: DEVICE

Placebo

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lesaffre International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermscan

Villeurbanne, , France

Countries

France

Other Identifiers

15E2899

Identifier Type: -

Identifier Source: org_study_id