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

NCT07570043 | Completed

• 1 other identifier: ABL-032503
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perimenopause; Menopausal Symptoms; Microbiome; Menopause-Related Quality of Life

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline to Week 4

Secondary Outcomes (5)

• Change in stool microbiome alpha diversity from baseline to Week 4

  Baseline to Week 4

• Change in stool microbial taxonomic composition from baseline to Week 4

  Baseline to Week 4

• Change in vaginal microbiome alpha diversity from baseline to Week 4

  Baseline to Week 4

• Change in relative abundance of vaginal microbial taxa from baseline to Week 4

  Baseline to Week 4

• Change in vaginal pH from baseline to Week 4

  Baseline to Week 4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Supplement

EXPERIMENTAL

Dietary Supplement: Supplement

Interventions

Supplement DIETARY_SUPPLEMENT

Active supplement

Supplement

Placebo OTHER

Inactive supplement

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Able Biolabs, LLC: lead

Study Sites (1)

Able Biolabs LLC

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: March 4, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 27, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)