Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis

Candidiasis, Vulvovaginal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02859493
• Other study ID #: 15E2899
• Status: Terminated
• Phase: N/A
• Start date: August 2016

Study information

• Verified date: June 2018
• Source: Lesaffre International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal

Intervention

Device:
• Saccharomyces cerevisiae

• Placebo

Locations

Country	Name	City	State
France	Dermscan	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Lesaffre International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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