An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement (NCT07453693) | Clinical Trial Compass
RecruitingNot Applicable
An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement
United States210 participantsStarted 2025-07-07
Plain-language summary
This is a 6-month, three-arm randomized controlled trial evaluating the efficacy and safety of a dietary supplement drink mix on urinary health outcomes in adult females. Participants will be randomly assigned to one of three study arms and followed for six months to assess changes in urinary health measures.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Healthy biological females who are 18-75 years of age (inclusive).
✓. Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months).
✓. Are within 7 days of the enrollment trigger event (acute UTI).
✓. In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product.
✓. BMI 18.5-39.9 kg/m\^2
✓. Have reliable, stable access to Wi-Fi and a smart phone/device.
✓. Willing and able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read questionnaires, and able to carry out all study-related procedures.
Exclusion criteria
✕. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
✕. Active participation in a clinical trial.
✕. Use of any treatment for menopausal outcomes or other concomitant treatments.
✕. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
✕. History of hyperkalemia (high potassium).
What they're measuring
1
Time to recurrence of clinically suspected UTI
Timeframe: 6 months
2
Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8)
Timeframe: 6 months
3
Ratio of Good to Bad Urinary Health Days
Timeframe: 6 months
4
Patient Global Impression of Change (PGIC)
Timeframe: 6 months
5
Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ)
Timeframe: 6 months
6
Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C