Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events
研究概览
简要总结
The goal of this clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together accounting for greater than 85% of known genes in this species. The intervention will be compared to a placebo intervention and will aim to assess the following in a healthy female population:
Measure changes in the relative and absolute abundance of a bacterial species, Lactobacillus crispatus, in the vagina, compared the baseline (prior to use of the personal care product) to two time points after use.
Observe changes in vaginal pH and self-reported discomfort from vaginal odor, compared the baseline to two time points after use.
Determine the user experience of three variations of a personal care product administered in different formats to improve vaginal health and establish tolerability and user acceptability.
Participants will use the personal care product according to a specific program as directed, conduct vaginal swab sampling, and answer questionnaires, each at eight time points.
详细描述
The vaginal microbiome is a dynamic microecosystem that undergoes fluctuations during the female menstrual cycle and at various life stages from puberty to menopause. A healthy vaginal microbiome is dominated by Lactobacillus which regulates vaginal pH, produces antimicrobial compounds, and significantly influences host immune response. The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a Lactobacillus postbiotic, prebiotic, and multiple strains of Lactobacillus crispatus predictive of a stable vaginal microbiome.
This study will be a randomized double-blind, placebo-controlled intervention that will examine the safety and tolerability of a personal care product for vaginal health, VM-02. This pilot study will last for the duration of two complete menstrual cycles. Data will be collected via participant virtual questionnaires and vaginal swabs.
Participants are randomized as follows:
A two-arm randomized, double-blind, placebo-controlled study to evaluate VM-02 as a vaginal suppository capsule.
Arm #1: Vaginal application of single-use applicators filled with a vaginal suppository capsule at 5 x 10^8 CFU/dose. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to this study being double-blind, participants will not know if they are in the condition with the test product or the placebo. Neither the test products nor the placebo used during the study will be labeled in any way that will indicate whether participants are taking the placebo or the test product. Participants will just know there is a chance they were randomized into a placebo or test product arm of the study. As mentioned above, only the Research Coordinator will know which group the participant is randomized into. The PI will remain blinded throughout the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reproductive age women aged ≥
- •History of regular menses every 21-35 days for six months prior to the study.
- •Agreement not to use specified intra-vaginal products during the study product use.
- •Willing to use an intra-vaginal suppository or dietary supplement during the study period.
- •Willing to complete vaginal swabs on themselves as directed in the study.
- •Ability to understand and read English and provide written consent.
排除标准
- •Pregnancy or planned pregnancy in the next 6 months.
- •Two or more amenorrheic months in the past 6 months.
- •Lives in the state of New York.
- •Allergy to any components of the supporting or excipient ingredients in test formulation capsules, tablets, placebos or over-the-counter competitor product.
结局指标
主要结局
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events
时间窗: Throughout intervention and subsequent 4 week period following last dose
次要结局
- Vaginal colonization calculated by detection of each of 3 distinct Lactobacillus crispatus strains after administration of VM-02 at 5 x 10^8 CFU/dose using metagenomic sequencing and/or strain-specific PCR-based assays(2 and 4 weeks after intervention)