Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis

NCT02859493 | Terminated DMC

• 1 other identifier: 15E2899
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Saccharomyces cerevisiae

ACTIVE COMPARATOR

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

Device: Saccharomyces cerevisiae

Maize starch and magnesium stearate

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

Saccharomyces cerevisiae DEVICE

Saccharomyces cerevisiae

Placebo DEVICE

Maize starch and magnesium stearate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Lesaffre International: lead

Study Sites (1)

Dermscan

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)