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NCT Number: NCT07268404

Women's Hormonal and Metabolic Wellbeing Study

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

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Interested in participating?

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alethios, Inc.

San Francisco, California, 94109, United States

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic Blend Capsule

Dietary Supplement

Hormone Balance Probiotic Blend

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Women's Health Quality of Life Scores

    Time frame: From baseline to week 12

    Women's Health Quality of Life as measured by changes in total and domains scores on the Health-Related Quality of Life Questionnaire for Polycystic Ovary Syndrome-26 (PCOSQ-26). Response Scale: 7-Point Likert Scale Per-Item Range: minimum: 1, maximum: 7, where higher scores indicate better outcomes.

Secondary outcomes

  1. Overall Health Quality of Life Scores

    Time frame: 12 weeks

    Assessed by monthly Patient-Reported Outcomes Measurement Information System - 29 Profile (PROMIS-29) questionnaire. 28 items use 5-point Likert scale responses (0-4), 1 item is a numeric rating scale (0-10). For negatively-worded concepts higher scores indicate worse outcomes, for positively-worded concepts higher scores indicate better outcomes.

  2. Change from baseline to Week 12 in Fasting Blood Glucose

    Time frame: 12 weeks

    Fasting Blood Glucose will be analyzed from dried blood spots (DBS), reported as mg/dL (milligrams per deciliter).

  3. Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c)

    Time frame: 12 weeks

    HbA1c will be analyzed from dried blood spots (DBS), reported as percentage (%).

  4. Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP).

    Time frame: 12 weeks

    hsCRP will be analyzed from dried blood spots (DBS), reported as mg/L (milligrams per liter).

  5. Supplementary Question - Sleep

    Time frame: 12 weeks

    Over the past 7 days, how would you rate your sleep quality overall? Visual Analog Scale, (0 = very poor, 10 = excellent) Over the past 7 days, how would you rate your energy level? Visual Analog Scale (0 = no energy/extremely fatigued, 10 = full energy/not fatigued at all)

  6. Supplementary Question - Acne Severity

    Time frame: 12 weeks

    How would you rate the severity of your acne over the past 7 days? Visual Analog Scale, (Response: 0-10 scale, where 0 = no acne and 10 = severe acne)

  7. Supplementary Question - Acne

    Time frame: 12 weeks

    To what extent does your acne currently affect your quality of life? (Response: 5-point Likert, from 'not at all' to 'extremely')

  8. Supplementary Question - Sexual Health

    Time frame: 12 weeks

    Over the past 7 days, how would you rate your overall sexual interest and satisfaction? Visual Analog Scale (0 = Very poor, 10 = Excellent)

Sponsors and collaborators

Lead sponsor

Daily Nouri

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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