CompletedNot Applicable

A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women

United States80 participantsStarted 2026-03-04

Plain-language summary

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.

Who can participate

Age range

35 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 suppleme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Greene Climacteric Scale total score from baseline to Week 4

Timeframe: Baseline to Week 4

Changes in gut microbiota composition associated with hormonal health

Timeframe: 4 weeks

Change in Cervantes Short Form total score from baseline to Week 4

Timeframe: Baseline to Week 4

Trial details

NCT IDNCT07570043

SponsorAble Biolabs, LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-15

View on ClinicalTrials.gov More Perimenopause trials