Recruiting

Dietary Supplement

Sponsor:

Bonafide Health

Code:

NCT07453693

Conditions

UTI's

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

FLUSH

Study Details

Brief 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.

Conditions

UTI's

Study ID

NCT07453693

Start date

Jul 7, 2025

Status verified date

Mar, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

FLUSH

2g D-Mannose drink mix

Primary outcome measure

  • Time to recurrence of clinically suspected UTI [ Time Frame: 6 months ]
  • Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8) [ Time Frame: 6 months ]
  • Ratio of Good to Bad Urinary Health Days [ Time Frame: 6 months ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: 6 months ]
  • Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ) [ Time Frame: 6 months ]
  • Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Bonafide Health

Recruiting

Harrison, New York, United States, 10528

Contacts

Trisha VanDusseldorp, Senior Director of Clinical Research, PhD

233-266-2343tvandusseldorp@bonafidehealth.com

Principal Investigator:

Trisha VanDusseldorp, PhD

More Information

Sponsor

Bonafide Health

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • UTI
  • D-Mannose
  • Dietary Supplement
  • Urinary tract infections
  • Recurrent UTIs
  • Drink Mix

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bonafide Health on 2026-03-06.