A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of a Postbiotic Supplement (resW) on Menopausal Symptoms and Hormonal Balance in Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in menopausal symptoms
研究概览
简要总结
The goal of this consumer health study is to evaluate the effect of resW™ Perimenopause Postbiotic on menopausal symptom severity, menopause-related quality of life, and selected microbiome-related outcomes in generally healthy perimenopausal women aged 35 to 55 years.
Participants will be randomized to receive either the active supplement or placebo daily for 4 weeks. Participants will complete electronic questionnaires at baseline and during the study. A predefined subset of participants will also complete stool and vaginal sample collection at baseline and Week 4.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group consumer health study evaluating the effect of resW™ Perimenopause Postbiotic in generally healthy perimenopausal women aged 35 to 55 years.
Eligible participants will be randomized in a 1:1 ratio to receive either resW™ Perimenopause Postbiotic or placebo for 4 weeks. Participants will take 2 capsules daily and complete electronic study questionnaires through the Chloe app. Menopausal symptom severity and menopause-related quality of life will be assessed using the Greene Climacteric Scale and Cervantes Short Form at baseline and Week 4, with an interim Greene Climacteric Scale assessment at Week 2.
A predefined microbiome substudy subset of approximately 20 participants will complete stool and vaginal sample collection at baseline and Week 4. These samples will be used to evaluate exploratory changes in stool microbiome composition, vaginal microbiome composition, and vaginal pH.
Safety and tolerability will be monitored throughout the study through adverse event reporting, compliance tracking, and participant-reported feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary, signed, and dated informed consent.
- •Female, aged 35 to 55 years, inclusive.
- •Currently experiencing perimenopausal symptoms, such as hot flashes, mood changes, sleep disturbance, or irregular cycles.
- •In generally good health as determined by self-reported medical history.
- •Agree to maintain existing diet, exercise, and lifestyle patterns throughout the study period.
- •Able and willing to comply with all study procedures, including electronic consent, app-based data entry, and study questionnaires.
- •Participants selected for the microbiome substudy must be willing to complete stool and vaginal sample collection.
- •Females of childbearing potential must agree to use a medically acceptable form of birth control during the study.
- •Agree to refrain from taking other probiotic, prebiotic, postbiotic, hormonal, or menopause-support supplements during the study.
- •Have reliable internet or smartphone access.
排除标准
- •Currently pregnant, planning to become pregnant, or breastfeeding.
- •History or current diagnosis of gynecologic disorders or other conditions affecting hormonal balance.
- •Current or recent use of hormone replacement therapy or hormonal medications.
- •History of unstable or newly diagnosed cardiovascular, hepatic, renal, or significant metabolic disorders.
- •Known gastrointestinal disease or condition affecting absorption or metabolism.
- •Known allergy or sensitivity to any ingredient in the study supplement.
- •Current participation in another clinical study involving an investigational product or device, or participation in such a study within the past 30 days.
- •Any other medical or psychiatric condition that, in the opinion of the investigator or study team, could interfere with study participation, compliance, or interpretation of study results.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Supplement
干预措施: Supplement (Dietary Supplement)
结局指标
主要结局
Improvement in menopausal symptoms
时间窗: 8 weeks
Changes in gut microbiota composition associated with hormonal health
时间窗: 8 weeks
次要结局
未报告次要终点