An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement

Recruiting now · Not applicable

Conditions studied: UTI's

In brief

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.

Key facts

Study ID

NCT07453693

Run by

Bonafide Health

People needed

210

Starts

2025-07-07

Expected to finish

2026-12-15

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• History of Chronic Kidney Disease.
• Introduction of antibiotics unrelated to a UTI occurrence during the trial period.
• Current use of D-mannose (participants may complete a 2-week washout period).
• Has previously used the FLUSH product.
• Current use of antibiotic-based prophylaxis.
• History of Diabetes mellitus (Type 1 and/or 2).
• Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days).
• Active or suspected vaginitis.
• Started a new nonantibiotic-based prophylaxis within the last 90 days.
• Use of probiotics (permitted if orally administered with stable dose longer than 90 days).
• Use of indwelling or intermittent urinary catheterization.
• Diagnosis of overactive bladder (OAB) or interstitial cystitis /bladder pain syndrome (IC/BPS).
• Urologic procedure within 6 months prior to trial enrollment.
• History of structural urinary tract disease.
• History of Lichen sclerosis.
• Use of potassium-sparing medications. o E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.

Where it is running

• Bonafide Health — Harrison, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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