NCT07246161招募中2 期
Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults
Lallemand Health Solutions1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年10月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake
研究概览
简要总结
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
详细描述
Probiotics have emerged as novel supplements to support women's health, demonstrating benefits in maintain vaginal health and promoting recovery from dysbiosis. This includes various oral and vaginal probiotics shown to alleviate symptoms and enhance the reversal of vaginal dysbiosis.
Oral delivered probiotic strains suggest their ability to migrate and transiently colonize the vagina to support vaginal health but is not well understood. Therefore, this study will aim to provide additional information on their transit to the vagina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Clinically healthy female between the ages of 18 and 50 years, inclusive,
- •have a regular or predictable menstrual cycle
- •Typically have regular bowel movements,
- •Willing and able to consume a probiotic supplement for 4 weeks,
- •Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,
- •Willing to discontinue fiber supplements 2 weeks before the start of the study, and throughout the study,
- •Willing to provide 1 stool sample 4 times throughout the study,
- •Willing to provide 2 vaginal swabs 4 times throughout the study,
- •Willing to undergo vaginal pH swab measurements (with a swab) 5 times throughout the study,
- •Willing to provide 2 perineal skin swabs (skin between the vagina and the anus) 3 times throughout the study,
- •Willing to complete a pregnancy test at the screening visit.
排除标准
- •Menopausal women,
- •Vaginal pH < 2 or > 5 measured at screening,
- •. Menstruation during the sample collection times,
- •Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
- •Use of vaginal probiotics in the last 3 months,
- •Use of local vaginal antibiotics or antifungals in the last 3 months.
- •Use of oral antibiotics or antifungals in the last month,
- •Ongoing symptoms of vaginal and/or urinary tract infections,
- •Current treatment for vaginal sepsis or urosepsis,
- •Currently being treated for a severe chronic disease (e.g. cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),
- •Clinical diagnosis of a gynecological disease or condition (e.g, fibroma, endometriosis, polycystic ovarian syndrome, etc.),
- •Clinical diagnosis of secondary dysmenorrhea,
- •Intolerance, allergy or sensitivity to milk, soy, or yeast.
研究组 & 干预措施
Group 2
Experimental
干预措施: Probiotic Formula 2 (Other)
Group 3
Experimental
干预措施: Probiotic Formula 3 (Other)
Group 1
Experimental
干预措施: Probiotic Formula 1 (Other)
结局指标
主要结局
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake
时间窗: 28 days of oral intake
次要结局
- Viability of the probiotic strains recovered from vaginal swabs at days 0, 14, and 28 of oral intake, and 1 week after the end of the intervention (Day 35)(From enrollment to the 35th day.)
- Viability of the probiotic strains recovered from perineal skin swabs at day 0, 14, and 28 of oral intake.(From enrollment to 28th day)
- Presence or absence of the probiotic stains in the vaginal swabs at days 0 & 14 of oral intake, and 1 week after the end of intervention (Day 35)(From enrollment to day 35)
- Presence or absence of the probiotic strains in perineal skin swabs at days 0, 14, and 28 of oral intake.(From enrollment to the 28th day.)
- Presence or absence of the probiotic strains in stool samples at days 0, 14 and 28 of oral intake.(From enrollment to 28th day)
- Changes in vaginal pH from baseline to 1 week after the end of the intervention (Day 35)(From baseline to day 35.)
- Changes in the abundance of endogenous and pathogenic bacterial and fungal species in the vagina at days 0, 14, 28 and 35.(From enrollment to the 35th day)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Global Effects of a Probiotic Strain on Lactating WomenMastitisNCT01124448Universidad Complutense de Madrid40
Unknown
1 期
Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza VaccinesInfluenzaNCT00294788Probiomics Ltd300
Unknown
不适用
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing EnterocolitisDeathNecrotizing EnterocolitisNCT02552706Shenzhen Bao'an Maternal and Child Health Hospital270
已完成
不适用
Effect of a Probiotic Water on Oral Health in AdultsOral BacteriaHalitosisNCT04473404Dose Biosystems Inc.48
已完成
不适用
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.Late Onset Neonatal SepsisInfant, Very Low Birth WeightNecrotizing EnterocolitisNCT02073214IBSS Biomed S.A.182