UTI's
Conditions
Keywords
UTI, D-Mannose, Dietary Supplement, Urinary tract infections, Recurrent UTIs, Drink Mix
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.
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.
Interventions
DIETARY_SUPPLEMENTFLUSH
2g D-Mannose drink mix
Sponsors
Bonafide Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, controlled, parallel allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence of clinically suspected UTI | 6 months | Time (days) to recurrence of clinically suspected UTI |
| Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8) | 6 months | 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. |
| Ratio of Good to Bad Urinary Health Days | 6 months | 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. |
| Patient Global Impression of Change (PGIC) | 6 months | 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. |
| Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ) | 6 months | 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. |
| Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with ≥1 Clinically Suspected UTI | 6 months | The proportion of participants who develop at least one clinically suspected UTI within 6 months of randomization. |
| Proportion of Participants with ≥1 Culture-Proven UTI | 6 months | The proportion of participants who develop at least one culture- proven UTI within 6 months of randomization. |
| Proportion of Participants with ≥1 Antibiotic-Treated UTI | 6 months | The proportion of participants who receive a course of antibiotics within 6 months of randomization for UTI. |
| Patient Global Impression of Severity (PGIS) | 6 months | 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. |
| Product Experience Questionnaire (PEQ) | 6 months | 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. |
Countries
United States
Outcome results
None listed