A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in symptoms of bacterial vaginosis.
研究概览
简要总结
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Women aged 18-40
- •Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
- •Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:
- •Unusual vaginal discharge ( thin, grayish-white or milky discharge that has a strong, fishy odor)
- •Changes in vaginal odor (i.e. An unpleasant "fishy" odor)
- •Vaginal itching or irritation
- •Discomfort or burning sensation during urination
- •Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:
- •Abdominal pain or discomfort
- •Changes in bowel habits i.e. diarrhea, constipation, or a combination of both.
- •Gas or flatulence
- •Changes in stool appearance
- •Mucus in the stool
- •Generally healthy - don't live with any uncontrolled chronic diseases
- •Willing to avoid the use of any intra-vaginal products (such as vaginal creams, gels, or medications) as well as suppositories during the study product use
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Planning to undergo any procedure related to their reproductive health.
- •Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
- •Anyone with known severe allergic reactions
- •Women who are pregnant, breastfeeding, or attempting to become pregnant
- •Unwilling to follow the study protocol
- •Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer
- •Anyone who has changed or stopped taking hormonal birth control in the last 3 months
结局指标
主要结局
Changes in symptoms of bacterial vaginosis.
时间窗: Baseline to Week 12
Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis.
Changes in vaginal odor.
时间窗: Baseline to Week 12
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal odor. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Changes in vaginal itchiness.
时间窗: Baseline to Week 12
Participants will complete self-reported questionnaires reporting the severity of vaginal itching. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
Changes in vaginal discharge.
时间窗: Baseline to Week 12
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal discharge. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Changes in vaginal dryness.
时间窗: Baseline to Week 12
Participants will complete self-reported questionnaires reporting the severity of vaginal dryness. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
次要结局
- Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).(Baseline to Week 12)
- Changes in scores on the Bristol Stool Chart.(Baseline to Week 12)