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NCT07268404NARecruitingAccepts Healthy Volunteers

Women's Hormonal and Metabolic Wellbeing Study

Daily Nouri

Start Date

12/1/2025

Completion Date

12/1/2026

Summary

The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women. Participants will: * Take the probiotic blend or placebo every day for 12 weeks * Complete virtual assessments and report symptoms throughout the study

Detailed Description

This study is a 12-week, prospective, randomized, controlled clinical trial. It is an interventional study with participants assigned to either an active or control group. All study visits will be conducted virtually, including completion of questionnaires, collection of blood samples, and other assessments.

Eligibility Criteria

Age Range: 18 years to 45 years

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.

Interventions

DIETARY_SUPPLEMENT

Probiotic Blend Capsule

DIETARY_SUPPLEMENT

Placebo

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Conditions

Metabolic Health

Locations

Alethios, Inc.

San Francisco, California 94109

United States