Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
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Participants will:
* Take the probiotic blend or placebo every day for 12 weeks
* Complete virtual assessments and report symptoms throughout the study
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention: Dietary Supplement Capsule
Hormone Balance Probiotic blend
Probiotic Blend Capsule
Hormone Balance Probiotic Blend
Placebo: Capsule
Identical capsule containing inactive ingredients
Placebo
Placebo
Interventions
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Probiotic Blend Capsule
Hormone Balance Probiotic Blend
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Daily Nouri
INDUSTRY
Responsible Party
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Locations
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Alethios, Inc.
San Francisco, California, United States
Countries
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Facility Contacts
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Alethios
Role: primary
Other Identifiers
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DNO001_14865
Identifier Type: -
Identifier Source: org_study_id