An interventional study of FLUSH in UTI's, sponsored by Bonafide Health. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Bonafide Health · Not applicable, Interventional, and Prevention
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.
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.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's planned enrollment of 210 is above the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Bonafide Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily dosing of FLUSH
Dietary Supplement: FLUSH
Dosing FLUSH once every 3 days and after sex if sexually active
Dietary Supplement: FLUSH
No study product administered. Maintain current UTI prevention measures.
2g D-Mannose drink mix
Time to recurrence of clinically suspected UTI
Time (days) 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)
Change from baseline to 6 months in total score on the Urinary Tract Infection Symptom and Impairment Questionnaire (UTI-SIQ-8). The UTI-SIQ-8 consists of 8 items scored from 1 to 5. Total scores range from 8 to 40, with higher scores indicating worse urinary tract infection symptom severity and impairment.
Time frame: 6 months
Ratio of Good to Bad Urinary Health Days
Ratio of self-reported "good urinary health days" to "bad urinary health days" recorded in daily electronic diaries over 6 months. A higher ratio indicates a greater proportion of good urinary health days relative to bad urinary health days.
Time frame: 6 months
Patient Global Impression of Change (PGIC)
Patient-reported global impression of change at 6 months as measured by the Patient Global Impression of Change (PGIC). The PGIC is a 7-point ordinal scale ranging from 1 (Very much improved) to 7 (Very much worse). Higher scores indicate worse perceived change.
Time frame: 6 months
Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ)
Change from baseline to 6 months in total score on the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ). Total scores range from 0 to 100, with higher scores indicating greater negative impact of recurrent urinary tract infections on quality of life.
Time frame: 6 months
Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C
Change from baseline to 6 months in Section C score of the Recurrent Urinary Tract Infection Symptom Scale (RUTISS). Section C items are scored on an 11-point numeric rating scale (0-10) and transformed to a total score ranging from 0 to 100. Higher scores indicate greater urinary tract infection symptom severity.
Time frame: 6 months
Proportion of Participants with ≥1 Clinically Suspected UTI
The proportion of participants who develop at least one clinically suspected UTI within 6 months of randomization.
Time frame: 6 months
Proportion of Participants with ≥1 Culture-Proven UTI
The proportion of participants who develop at least one culture- proven UTI within 6 months of randomization.
Time frame: 6 months
Proportion of Participants with ≥1 Antibiotic-Treated UTI
The proportion of participants who receive a course of antibiotics within 6 months of randomization for UTI.
Time frame: 6 months
Patient Global Impression of Severity (PGIS)
Symptom severity at Baseline, 2 months, 4 months, and 6 months as measured by the Patient Global Impression of Severity (PGIS). The PGIS is a 5-point ordinal scale ranging from 1 (No symptoms) to 5 (Very severe symptoms). Higher scores indicate greater symptom severity.
Time frame: 6 months
Product Experience Questionnaire (PEQ)
Difference between treatment arms in total score on the Product Experience Questionnaire (PEQ) at Months 1, 3, and 6. The PEQ total score ranges from 1 to 4, with higher scores indicatingless favorable product experience.
Time frame: 6 months
Plan to share: No
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Bonafide Health