An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement
Bonafide Health · NCT07453693
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 210
- US sites recruiting
- 1
- Study start
- July 7, 2025
- Record last updated
- March 6, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: FLUSH
Conditions: UTI's
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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).
- 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.
Recruiting US locations
Bonafide Health
Harrison, NY 10528
Site contact: Trisha VanDusseldorp, Senior Director of Clinical Research, PhD · 233-266-2343 · tvandusseldorp@bonafidehealth.com
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