Microbiome and Wellbeing Modulation in Women: An Exploratory Probiotic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cultech Ltd
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in wellbeing through the use of wellbeing diaries
研究概览
简要总结
Investigation into the effect of probiotic supplementation on the wellbeing of women with a history of vaginal discomfort and/or irritation, along with any microbiome changes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy menstruating women (female at birth), 18 to 40 years old with history of 3 or 4 episodes of vaginal discomfort (1 or more days) involving itching, burning sensation and/or odorous discharge in the past 12 months
- •Willing to start on completion of monthly cycle (< 5 days post completion)
- •Willing to provide vaginal and faecal samples
- •Willing to maintain normal diet and lifestyle during the study
- •Willing to refrain from taking other probiotic supplements during the study
- •Willing to refrain from sexual activity, the use of lubricants and vaginal cleaning (with antibacterials)/douching for 2 days prior to providing vaginal swabs
排除标准
- •Consumption of oral antibiotics within the last 2 months
- •Given birth in the last 3 months, currently pregnant or planning pregnancy
- •Currently experiencing (symptoms of) a vaginal or urinary infection
- •Immunodeficient or undergoing immunosuppressive therapy
- •Diagnosed with diabetes/cardiovascular disease/cancer/dementia
研究组 & 干预措施
Placebo
Matching placebo
干预措施: Placebo (Other)
Active
Lab4 Multi-strain Probiotic + Lactobacillus gasseri and Lactobacillus crispatus (comprising Lactobacilli and bifidobacteria species) with Vitamin A and Vitamin D
干预措施: Lab4 + Lactobacillus gasseri and Lactobacillus crispatus (Dietary Supplement)
结局指标
主要结局
Changes in wellbeing through the use of wellbeing diaries
时间窗: From date of randomization until the end of the intervention period (20 days)
Changes in wellbeing and in the composition of the microbiome
Changes in microbiome composition through shotgun Metagenomics
时间窗: From date of randomization until the end of the intervention period (20 days)
次要结局
未报告次要终点