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临床试验/NCT06506357
NCT06506357已完成不适用

A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.

Love Wellness2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Love Wellness
入组人数
40
试验地点
2
主要终点
Vaginal and Urinary Tract Health and Balance

研究概览

简要总结

This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female at birth.
  • Aged 18+.
  • Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.
  • Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
  • Willing to avoid using products or medications that target vaginal or urinary tract health infections.
  • Willing to avoid other probiotics.
  • Able to follow the study protocol.

排除标准

  • Two or more bladder infections in six months or three or more infections in a year.
  • Recent surgeries or invasive treatments within the last six months.
  • Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
  • Known allergies to the product ingredients.
  • Chronic health conditions impacting participation.
  • Pregnant, breastfeeding, or trying to conceive.
  • History of substance abuse.
  • Current or former smoker within the past six months.
  • Participation in another clinical trial.
  • Diagnosed vaginal or pelvic conditions.
  • Use of vaginal-related birth control (NuvaRing, IUD).
  • Changes in hormonal birth control in the last three months.

结局指标

主要结局

Vaginal and Urinary Tract Health and Balance

时间窗: Baseline, Week 2, Week 4, Week 6, Week 8

Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.

次要结局

  • Vaginal Environment and Odor(Baseline, Week 2, Week 4, Week 6, Week 8)

研究者

发起方
Love Wellness
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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