D‑mannose and vitamin drink mix for urinary health in women

A Randomized, Controlled Trial Evaluating the Efficacy of the FLUSH Dietary Supplement Drink Mix to Improve Urinary Health Measures

This six-month test will see if a drink mix with D‑mannose, vitamins, and electrolytes helps adult women who have recurrent UTIs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Bonafide Health (Industry-sponsored)
• Locations: 1 site (Harrison, New York)
• Trial ID: NCT07453693 on ClinicalTrials.gov

What this trial studies

This randomized, three-arm trial will follow adult biological females with recurrent uncomplicated UTIs for six months after enrollment and randomize them to one of three groups to receive a dietary supplement drink mix or comparison regimens. The investigational product contains D‑mannose, vitamins, and electrolytes intended to reduce bacterial adhesion and support hydration and urinary pH. Participants must be 18–75, within seven days of an acute UTI, have a history of ≥2 UTIs in 6 months or ≥3 in 12 months, and have smartphone/Wi‑Fi access, while pregnant or lactating persons and those using other concurrent treatments are excluded. Outcomes include urinary health measures and safety endpoints to determine whether the non‑antibiotic approach can reduce factors linked to recurrent UTIs.

Who should consider this trial

Good fit: Healthy biological females aged 18–75 with recurrent uncomplicated UTIs (≥2 in 6 months or ≥3 in 12 months), within seven days of an acute UTI, able to take the product and with reliable smartphone/Wi‑Fi access are ideal candidates.

Not a fit: People who are pregnant or lactating, have complicated UTIs or uncontrolled medical conditions, are in another clinical trial, or require conflicting treatments may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the drink mix could reduce UTI recurrence and lower reliance on antibiotics.

How similar studies have performed: Smaller trials and observational studies of D‑mannose and other non‑antibiotic approaches have shown promising results, but large, high‑quality randomized trials are still limited.

Eligibility criteria

Inclusion Criteria:

1. 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:

1. 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.

Where this trial is running

Harrison, New York

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

Conditions UTI's; UTI; D-Mannose; Dietary Supplement; Urinary tract infections; Recurrent UTIs; Drink Mix