Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis [after 7 days and 14 days of treatment]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dermscan | Villeurbanne | France | 69100 |
Sponsors and Collaborators
- Lesaffre International
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15E2899