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

What this trial studies

The goal of this consumer study is to evaluate the efficacy of a postbiotic supplement on menopausal symptoms and hormonal balance in premenopausal women ages 35-55 (inclusive) who are generally healthy. The main question it aims to answer is: Will the postbiotic supplement improve menopausal symptoms in premenopausal women? If there is a comparison group: Researchers will compare placebo and active supplement to see if there is a statistically significant difference in effect. Participants will take the supplement/placebo daily for 8 weeks and complete questionnaires on a regular basis.

Conditions in scope

• Premenopause

Interventions

• Supplement (Dietary Supplement) — Active supplement
• Placebo (Other) — Inactive supplement

Who can join

Women only · Ages 35 Years to 55 Years · Accepts healthy volunteers.

Inclusion criteria

• Provide voluntary signed and dated informed consent
• Age between 35 and 55 years (inclusive)
• Have normal or acceptable vital signs (blood pressure and heart rate) and normal or acceptable physical exam findings at screening.
• Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
• Subject is willing and able to comply with the study protocol.
• Females of childbearing potential must agree to practice a medically acceptable form of birth control throughout the study.
• Agree to refrain from other probiotic, prebiotic, hormonal, or menopause-support supplements during the duration of the trial.

Exclusion criteria

• History of gynecological diseases or conditions.
• Current use of hormone replacement therapy (HRT).
• History of unstable or new-onset cardiovascular, renal, hepatic, or significant metabolic disorders.
• Known gastrointestinal conditions affecting absorption or metabolism.
• Pregnancy, lactation, or planning pregnancy during the study.
• Known sensitivity to any ingredient in the test formulations.
• Currently participating in another research study with an investigational product or have participated in another research study in the past 30 days.
• Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2026-03-04
• Primary completion: 2026-05-15
• Last update posted: 2026-05-06
• First posted: 2026-05-06

Sponsor & contact

Lead sponsor: Able Biolabs, LLC (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Improvement in menopausal symptoms (8 weeks)
• Changes in gut microbiota composition associated with hormonal health (8 weeks)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.