Alethios, Inc.
San Francisco, California, 94109, United States
Location status: Recruiting
NCT Number: NCT07268404
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
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
San Francisco, California, 94109, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Hormone Balance Probiotic Blend
Placebo
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.
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.
Time frame: 12 weeks
Fasting Blood Glucose will be analyzed from dried blood spots (DBS), reported as mg/dL (milligrams per deciliter).
Time frame: 12 weeks
HbA1c will be analyzed from dried blood spots (DBS), reported as percentage (%).
Time frame: 12 weeks
hsCRP will be analyzed from dried blood spots (DBS), reported as mg/L (milligrams per liter).
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)
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)
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')
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)
Daily Nouri
Industry
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
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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