Women's Hormonal and Metabolic Wellbeing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 12-week, randomized, placebo-controlled trial in which participants take either a probiotic blend capsule or matching placebo daily. All study visits are conducted virtually, including symptom questionnaires and remote reporting, while blood samples are collected at baseline and follow-up to measure metabolic and inflammatory markers. Eligible participants report irregular menstrual cycles for at least six months and at least one hormone-related concern and must not be using hormonal therapies, metformin, GLP-1 agonists, or anti-androgens. Participants taking menstrual/hormonal supplements must stop them for a two-week washout before baseline and remain weight-stable during the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Self-reported irregular menstrual cycles, defined as one or more of the following:

  * Cycle length typically \>35 days OR \<21 days
  * Fewer than 9 menstrual periods in the past year
  * Unpredictable cycle timing (varies by \>7 days month-to-month)
  * Irregular cycles present for ≥6 months
* One or more of the following hormonal balance concerns: skin, unwanted hair growth, hair thinning, weight concerns)
* Self-reported emotional symptoms that fluctuate with menstrual cycle, including:

  * Mood swings or irritability
  * Feelings of stress or tension
  * Low mood or feeling down
  * Difficulty with emotional regulation
* Not currently using hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens.
* If taking supplements for menstrual/hormonal support: willing to discontinue for 2-week washout before baseline
* Weight stable (+ 5 pounds) for the past 2 months, not planning to start a new diet, exercise program, or medications during study
* Able to provide electronic informed consent.
* Willing to complete online surveys and at-home DBS sample collection.
* Negative home pregnancy test at baseline.
* Access to a computer or smartphone and reliable internet connection.

Where it's running

• Alethios, Inc.
  San Francisco, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.