PerimenopauseRESW101NCT07570043
A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women
A study testing Supplement in people with Perimenopause and Menopausal Symptoms, run by Able Biolabs, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Menopausal Symptoms, Menopause-Related Quality of Life
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2026to 27 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Supplement, Placebo
- Keywords
- Perimenopause, Menopausal Symptoms, Postbiotic, Gut Microbiome, Women's Health, Hormonal Balance, Menopause, Vaginal Microbiome, Greene Climacteric Scale, Cervantes Short Form, Dietary Supplement, Microbiome, Non-hormonal Support, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Active supplement
PlaceboOther
Inactive supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Supplement | Experimental | Not described Receives: Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Greene Climacteric Scale total score from baseline to Week 4
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.
Measured: Baseline to Week 4
Changes in gut microbiota composition associated with hormonal health
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.
Measured: 4 weeks
Change in Cervantes Short Form total score from baseline to Week 4
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.
Measured: Baseline to Week 4
Secondary outcomes (5)
Change in stool microbiome alpha diversity from baseline to Week 4
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.
Measured: Baseline to Week 4
Change in stool microbial taxonomic composition from baseline to Week 4
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.
Measured: Baseline to Week 4
Change in vaginal microbiome alpha diversity from baseline to Week 4
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.
Measured: Baseline to Week 4
Change in relative abundance of vaginal microbial taxa from baseline to Week 4
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.
Measured: Baseline to Week 4
Change in vaginal pH from baseline to Week 4
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.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start4 Mar 2026
- Primary completion15 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Able Biolabs, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570043
- Sponsor's protocol ID
- ABL-032503
- Acronym
- RESW101
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07570043
- Acronym / sponsor ID
- RESW101 / ABL-032503
- Keywords
- Perimenopause, Menopausal Symptoms, Postbiotic, Gut Microbiome, Women's Health, Hormonal Balance, Menopause, Vaginal Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Able Biolabs, LLCUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Supplement | Experimental | Dietary Supplement: Supplement |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementActive supplement | Dietary supplement | Supplement |
| PlaceboInactive supplement | Other | Placebo |
Primary outcome
Change in Greene Climacteric Scale total score from baseline to Week 4
Time frame: Baseline to Week 4
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.
Changes in gut microbiota composition associated with hormonal health
Time frame: 4 weeks
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.
Change in Cervantes Short Form total score from baseline to Week 4
Time frame: Baseline to Week 4
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.
5 secondary outcomes
Change in stool microbiome alpha diversity from baseline to Week 4
Time frame: Baseline to Week 4
Change in stool microbial taxonomic composition from baseline to Week 4
Time frame: Baseline to Week 4
Change in vaginal microbiome alpha diversity from baseline to Week 4
Time frame: Baseline to Week 4
Change in relative abundance of vaginal microbial taxa from baseline to Week 4
Time frame: Baseline to Week 4
Change in vaginal pH from baseline to Week 4
Time frame: Baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Related trials for Perimenopause
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Exercise in Perimenopause to Improve Cognitive Health
Perimenopause, Subjective Cognitive Complaints
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Perimenopause and Menopausal Symptoms, run by Able Biolabs, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Greene Climacteric Scale total score from baseline to Week 4 (time frame: Baseline to Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.