An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement
Purpose
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.
Condition
- UTI's
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Healthy biological females who are 18-75 years of age (inclusive). 2. Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months). 3. Are within 7 days of the enrollment trigger event (acute UTI). 4. In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product. 5. BMI 18.5-39.9 kg/m^2 6. Have reliable, stable access to Wi-Fi and a smart phone/device. 7. 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. 2. Active participation in a clinical trial. 3. Use of any treatment for menopausal outcomes or other concomitant treatments. 4. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients. 5. History of hyperkalemia (high potassium). 6. History of Chronic Kidney Disease. 7. Introduction of antibiotics unrelated to a UTI occurrence during the trial period. 8. Current use of D-mannose (participants may complete a 2-week washout period). 9. Has previously used the FLUSH product. 10. Current use of antibiotic-based prophylaxis. 11. History of Diabetes mellitus (Type 1 and/or 2). 12. Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days). 13. Active or suspected vaginitis. 14. Started a new nonantibiotic-based prophylaxis within the last 90 days. 15. Use of probiotics (permitted if orally administered with stable dose longer than 90 days). 16. Use of indwelling or intermittent urinary catheterization. 17. Diagnosis of overactive bladder (OAB) or interstitial cystitis /bladder pain syndrome (IC/BPS). 18. Urologic procedure within 6 months prior to trial enrollment. 19. History of structural urinary tract disease. 20. History of Lichen sclerosis. 21. Use of potassium-sparing medications. o E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, controlled, parallel allocation
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator FLUSH Daily Dosing |
Daily dosing of FLUSH |
|
|
Active Comparator FLUSH 3-Day Dosing |
Dosing FLUSH once every 3 days and after sex if sexually active |
|
|
No Intervention Standard of Care |
No study product administered. Maintain current UTI prevention measures. |
|
Recruiting Locations
Harrison, New York 10528
Trisha VanDusseldorp, Senior Director of Clinical Research, PhD
233-266-2343
tvandusseldorp@bonafidehealth.com
More Details
- Status
- Recruiting
- Sponsor
- Bonafide Health
Study Contact
Detailed Description
Urinary tract infections (UTIs) are extremely common, affecting up to 60% of women in their lifetime, with 20-40% experiencing recurrent infections. Recurrent UTIs-defined as two infections in six months or three in one year-create a significant burden on quality of life and healthcare costs. Antibiotics are the standard treatment, but repeated use can contribute to antibiotic resistance, incomplete bacterial clearance, and disruption of the microbiome. Non-antibiotic approaches, such as D-mannose, vitamins, and hydration support, have shown potential to help reduce UTI recurrence. D-mannose may prevent E. coli-the most common UTI-causing bacteria-from adhering to the urinary tract, while vitamins and electrolytes may support hydration, urinary pH, and immune function. This clinical trial will evaluate the efficacy of a dietary supplement drink mix containing D-mannose, vitamins, and electrolytes in improving urinary health outcomes over a 6-month period in adult females. The goal is to determine whether this non-antibiotic approach can support urinary health and help reduce factors associated with recurrent UTIs.