NCT02859493终止不适用
Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
Saccharomyces cerevisiae
Active Comparator
Inactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days.
干预措施: Saccharomyces cerevisiae (Device)
Maize starch and magnesium stearate
Placebo Comparator
Placebo presented in a vaginal capsule. 1 capsule a day for 14 days
干预措施: Placebo (Device)
结局指标
主要结局
Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (2)
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