NCT03543982已完成不适用
An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health
UAS Labs LLC2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年5月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Changes in vaginal microbial community, via next generation sequencing.
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women aged 18-50 years.
- •Body mass index 18.5 - 34.9 kg/m2 (inclusive).
- •Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater than one year since last menses)].
- •Non-smoker, or ex-smoker ≥6 months.
- •Nugent score of 4-6 or pH >4.5
- •Agrees to maintain current level of physical activity and dietary habits throughout the trial period.
- •Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food supplemented with probiotics or prebiotics.
- •Willing and able to provide written informed consent.
- •Agrees to provide fecal samples during the trial period.
排除标准
- •Hypersensitivity to any ingredient in the study product.
- •Pregnancy or planning pregnancy.
- •Lactation or breast feeding.
- •Irregular menstrual cycles.
- •Use of contraceptives that contain spermicidal agents.
- •Use of an intrauterine device (IUD).
- •Use of hormonal therapy through cervical cap.
- •Use of douching devices.
- •Any major trauma or surgical event within the 3 months prior to screening.
- •Individuals undergoing therapies to prevent any recurrent infections.
- •Allergy to any antibiotic that may be prescribed as a rescue remedy during the study.
- •Use of prescription drugs (other than birth control) within 1 month prior to Visit
- •Use of antibiotics within 2 months prior to Visit
- •History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
- •Presence of systemic diseases or immunodeficiencies
- •Abdominal or gastrointestinal surgery within the previous 12 months.
- •Recent gastrointestinal food-borne illness (within 1 month prior to Visit 1)
- •History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
- •Abnormal laboratory test results of clinical significance
- •Presence or history (past 6 months) of alcohol or drug abuse
- •Subject is unwilling or unable to abide by the requirements of the protocol
- •Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
- •Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit
结局指标
主要结局
Changes in vaginal microbial community, via next generation sequencing.
时间窗: Day 28
次要结局
- Changes in vaginal microbial community, via next generation sequencing.(Day 14 and 42)
- Parameters of well-being, via Vulvovaginal Symptom Questionnaire.(Day 14, 28 and 42)
- Changes in vaginal pH.(Day 14, 28 and 42)
- Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.(Day 14, 28 and 42)
- Compliance as assessed by capsule counts of the returned IP.(Day 14, 28 and 42)
- Changes in Nugent Score (Scale of 0 to 10).(Day 14, 28 and 42)
研究者
研究点 (2)
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