An interventional study of Probiotic Blend Capsule and Placebo in Metabolic Health, sponsored by Daily Nouri. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Daily Nouri · Not applicable, Interventional, and Supportive care
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:
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.
Daily Nouri is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Self-reported irregular menstrual cycles, defined as one or more of the following:
Self-reported emotional symptoms that fluctuate with menstrual cycle, including:
Hormone Balance Probiotic blend
Dietary Supplement: Probiotic Blend Capsule
Identical capsule containing inactive ingredients
Dietary Supplement: Placebo
Hormone Balance Probiotic Blend
Placebo
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.
Time frame: From baseline to week 12
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.
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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')
Time frame: 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)
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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