RecruitingNot ApplicableNCT07268404

Women's Hormonal and Metabolic Wellbeing Study

A 12-Week Virtual, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of Daily Nouri Hormone Balance Probiotic on Metabolic, Inflammatory, and Symptom Outcomes in Women


Sponsor

Daily Nouri

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria18

  • 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.

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Interventions

DIETARY_SUPPLEMENTProbiotic Blend Capsule

Hormone Balance Probiotic Blend

DIETARY_SUPPLEMENTPlacebo

Placebo


Locations(1)

Alethios, Inc.

San Francisco, California, United States

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NCT07268404


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