Women's Hormonal and Metabolic Wellbeing
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
This 12-week test will see if taking Daily Nouri's Hormone Balance probiotic every day helps women with irregular menstrual cycles and hormone-related symptoms improve metabolic markers, inflammation, and daily symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Daily Nouri Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07268404 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women with self-reported irregular menstrual cycles and one or more hormone-related concerns (such as skin issues, unwanted hair growth, hair thinning, or weight concerns) who are not currently using the excluded medications are the intended participants.
Not a fit: Individuals currently on hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens, or those unwilling to stop supporting supplements for the washout or provide required blood samples, are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the probiotic could provide a low-risk daily supplement option to reduce inflammation, improve metabolic measures, and relieve some hormone-related symptoms for some women.
How similar studies have performed: Some small trials have shown modest metabolic or inflammatory benefits from specific probiotic formulations, but evidence directly supporting probiotics for menstrual irregularity and related hormone symptoms remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- Alethios, Inc. — San Francisco, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.