A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women (RESW101)
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
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75247
- Able Biolabs LLC
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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Inactive supplement
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实验性的：补充
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Active supplement
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Greene Climacteric Scale total score from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in the Greene Climacteric Scale total score.
The Greene Climacteric Scale is a 21-item questionnaire assessing climacteric symptoms.
Total scores range from 0 to 63, with higher scores indicating greater climacteric symptom severity, which is a worse outcome.
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Baseline to Week 4
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Changes in gut microbiota composition associated with hormonal health
大体时间：4 weeks
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Change from baseline to Week 4 in gut microbiota composition assessed using stool sample microbiome sequencing.
Gut microbiota composition will be evaluated by measures including microbial taxonomic relative abundance and diversity metrics derived from sequencing data.
This outcome will assess changes in the composition of bacterial taxa in stool samples associated with hormonal health.
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4 weeks
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Change in Cervantes Short Form total score from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in the Cervantes Short Form Scale total score.
The Cervantes Short Form Scale is a validated menopause-specific quality-of-life questionnaire assessing menopause-related quality of life across physical, psychological, and aging-related domains.
Total scores range from 0 to 100, with higher scores indicating poorer menopause-related quality of life, which is a worse outcome.
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Baseline to Week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in stool microbiome alpha diversity from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in stool microbiome alpha diversity, assessed using diversity indices such as the Shannon diversity index, Simpson diversity index, or observed amplicon sequence variants/species richness, in participants enrolled in the microbiome substudy.
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Baseline to Week 4
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Change in stool microbial taxonomic composition from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in the relative abundance of stool microbial taxa, assessed using stool sample microbiome sequencing, in participants enrolled in the microbiome substudy.
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Baseline to Week 4
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Change in vaginal microbiome alpha diversity from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in vaginal microbiome alpha diversity, assessed using diversity indices such as the Shannon diversity index, Simpson diversity index, or observed amplicon sequence variants/species richness, in participants enrolled in the microbiome substudy.
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Baseline to Week 4
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Change in relative abundance of vaginal microbial taxa from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in the relative abundance of vaginal microbial taxa, including Lactobacillus species and bacterial vaginosis-associated taxa, assessed using vaginal sample microbiome sequencing, in participants enrolled in the microbiome substudy.
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Baseline to Week 4
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Change in vaginal pH from baseline to Week 4
大体时间：Baseline to Week 4
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Change from baseline to Week 4 in vaginal pH, measured from vaginal samples using a pH test method, in participants enrolled in the microbiome substudy.
Vaginal pH is measured on a continuous scale, with higher values indicating greater vaginal alkalinity.
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Baseline to Week 4
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- ABL-032503
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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