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

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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Health
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic Blend Capsule

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • Recruiting
      • Alethios, Inc.
      • Contact: Alethios; Phone Number: (650) 206-8006; Email: support@alethios.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Dietary Supplement Capsule; Hormone Balance Probiotic blend	Dietary supplement: Probiotic Blend Capsule; Hormone Balance Probiotic Blend
Placebo Comparator: Placebo: Capsule; Identical capsule containing inactive ingredients	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Women's Health Quality of Life Scores	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.	From baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Health Quality of Life Scores	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.	12 weeks
Change from baseline to Week 12 in Fasting Blood Glucose	Fasting Blood Glucose will be analyzed from dried blood spots (DBS), reported as mg/dL (milligrams per deciliter).	12 weeks
Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c)	HbA1c will be analyzed from dried blood spots (DBS), reported as percentage (%).	12 weeks
Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP).	hsCRP will be analyzed from dried blood spots (DBS), reported as mg/L (milligrams per liter).	12 weeks
Supplementary Question - Sleep	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)	12 weeks
Supplementary Question - Acne Severity	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)	12 weeks
Supplementary Question - Acne	To what extent does your acne currently affect your quality of life? (Response: 5-point Likert, from 'not at all' to 'extremely')	12 weeks
Supplementary Question - Sexual Health	Over the past 7 days, how would you rate your overall sexual interest and satisfaction? Visual Analog Scale (0 = Very poor, 10 = Excellent)	12 weeks

Collaborators and Investigators

• Sponsor: Daily Nouri

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; dietary supplement; women's health; hormone balance
• Other Study ID Numbers: DNO001_14865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No