A Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Colonization of VV-01 probiotic strains in the vagina
研究概览
简要总结
A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.
详细描述
This is a randomized, double-blind, placebo-controlled, decentralized clinical trial that will enroll approximately 200 healthy women aged 21-60 years old who meet all eligibility criteria. Eligible participants will be stratified based on key factors.
Following stratification, participants will be randomized to one of the study arms (placebo or VV-01 product) using block randomization. Participants will have a 1:1 chance of receiving the active study product or the placebo.
Participants will receive study kits containing the study product, administration supplies, biomarker self-collection materials, and comprehensive instructions for product use and sample collection.
The duration of the study for each participant will be approximately 2 weeks following enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator): The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all the following criteria:
- •Healthy women with a vagina 21 - 60 years old at the time of electronic consent
- •Sex assigned female at birth
- •Eligible menstrual status:
- •Pre-menopausal is defined as women in their childbearing years who must have a regular menstrual cycle (consistently average cycle length of 21 to 35 days) Note: Women in their childbearing years who do not have a regular menstrual cycle due to a hormone-based intrauterine device are eligible
- •Peri-menopausal is defined as women who report irregular periods (differences in menstruation compared with their typical cycle in their 20s), with at least 1 period in the last 12 months AND report mild menopausal symptoms (e.g., vasomotor symptoms such as hot flashes, night sweats)
- •Post-menopausal is defined as women with an absence of menstrual cycle for the last 12 consecutive months or longer
- •Willing to ingest an oral capsule during the study and be blinded to product identity (active or placebo)
- •Willing to self-collect vaginal swabs and pH samples
- •Willing to abstain from the use of intravaginal products during the study period (e.g., vaginal suppositories, vaginal moisturizers including hyaluronic acid, boric acid suppositories, pH balancing wipes, douching, vaginal creams/gels), as well as lubrication and spermicides
- •Able to read and comprehend English and provide electronic informed consent
- •Resides in the United States
排除标准
- •Active vaginal, pelvic, or urogenital infection (e.g., UTI, BV, yeast infection)
- •Chronic vulvar and vaginal conditions (e.g., vulvodynia, lichen sclerosis and lichen planus, desquamative inflammatory vaginitis)
- •Unexplained vaginal bleeding
- •Use of copper-based intrauterine devices
- •Note: Hormone-based intrauterine devices are permitted (e.g., Mirena®)
- •For peri-menopausal and post-menopausal individuals, use of estrogen-based vaginal cream/gel or suppositories
- •Women who have undergone surgical menopause (e.g., bilateral oophorectomy with or without hysterectomy)
- •Current or recent use (< 3 months prior to enrollment) of antibiotics or antifungals, or anticipated use during study period (e.g., perioperative antibiotics for upcoming elective procedures)
- •Current or recent use (<4 weeks prior to enrollment) of any other probiotic, prebiotic or synbiotic-containing products
- •Note: Individuals who undergo a washout of 4-weeks prior to enrollment and are willing to abstain from consuming such products during the study are permitted. Food-based probiotics, prebiotics, and synbiotics are permitted (e.g., kimchi, yoghurt, kefir, kombucha)
- •Pregnant, breastfeeding, or actively trying to conceive during the study period.
- •Allergy to any ingredients in the investigational or placebo product.
- •Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such treatment within 4 weeks of enrollment
- •Surgery, immunotherapy, chemotherapy, radiation, or biological cancer therapy within 4 weeks of enrollment and/or planned during the next 2 weeks
- •Diagnosed and active serious medical condition requiring current treatment (e.g., cancer; autoimmune diseases [lupus, rheumatoid arthritis, Crohn's disease]; serious cardiac, liver, endocrine (insulin-dependent diabetes and/or on SGLT2 inhibitors such as Jardiance®/Empagliflozin, Farxiga®/Dapagliflozin) or kidney disease; psychiatric conditions / substance use disorders; chronic infections [HIV, Hepatitis B/C], any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study
- •Participation in another clinical trial within 90 days of screening
- •International travel during the study period
研究组 & 干预措施
Placebo Control
Vaginal Health Placebo Control
干预措施: Vaginal Health Placebo Control (Dietary Supplement)
Active VV-01
Vaginal Health Active VV-01
干预措施: Vaginal Health Active VV-01 (Dietary Supplement)
结局指标
主要结局
Colonization of VV-01 probiotic strains in the vagina
时间窗: Baseline to Day 14
Colonization of VV-01 probiotic strains in the vagina assessed using strain-specific qPCR from vaginal swabs
次要结局
- Vaginal microbial ecosystem structure(Baseline to Day 14)
- Safety and tolerability(Baseline to Day 14)
- Biogenic amines production capability in the vaginal microbiome(Baseline to Day 14)