UTI'sNCT07453693
An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement
A study testing FLUSH in people with UTI's, run by Bonafide Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- UTI's
- What is being tested?
- FLUSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy biological females who are 18-75 years of age (inclusive).
- Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months).
- Are within 7 days of the enrollment trigger event (acute UTI).
- In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product.
- BMI 18.5-39.9 kg/m^2
- Have reliable, stable access to Wi-Fi and a smart phone/device.
- 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.
Who cannot join
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Active participation in a clinical trial.
- Use of any treatment for menopausal outcomes or other concomitant treatments.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- History of hyperkalemia (high potassium).
- History of Chronic Kidney Disease.
Show all 21Show fewer
- Introduction of antibiotics unrelated to a UTI occurrence during the trial period.
- Current use of D-mannose (participants may complete a 2-week washout period).
- Has previously used the FLUSH product.
- Current use of antibiotic-based prophylaxis.
- History of Diabetes mellitus (Type 1 and/or 2).
- Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days).
- Active or suspected vaginitis.
- Started a new nonantibiotic-based prophylaxis within the last 90 days.
- Use of probiotics (permitted if orally administered with stable dose longer than 90 days).
- Use of indwelling or intermittent urinary catheterization.
- Diagnosis of overactive bladder (OAB) or interstitial cystitis /bladder pain syndrome (IC/BPS).
- Urologic procedure within 6 months prior to trial enrollment.
- History of structural urinary tract disease.
- History of Lichen sclerosis.
- Use of potassium-sparing medications. o E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bonafide Health
Harrison, New York, 10528
Trisha VanDusseldorp, Senior Director of Clinical Research, PhD, 233-266-2343, tvandusseldorp@bonafidehealth.com
Trisha VanDusseldorp, PhD
About this study
Official title: A Randomized, Controlled Trial Evaluating the Efficacy of the FLUSH Dietary Supplement Drink Mix to Improve Urinary Health Measures
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.
Read the 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.
- Conditions
- UTI's
- Being tested
- FLUSH
- Keywords
- UTI, D-Mannose, Dietary Supplement, Urinary tract infections, Recurrent UTIs, Drink Mix
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUSHDietary supplement
2g D-Mannose drink mix
| Study group | Role | What they receive |
|---|---|---|
| FLUSH Daily Dosing | Active comparator | Daily dosing of FLUSH Receives: Dietary Supplement: FLUSH |
| FLUSH 3-Day Dosing | Active comparator | Dosing FLUSH once every 3 days and after sex if sexually active Receives: Dietary Supplement: FLUSH |
| Standard of Care | No intervention | No study product administered. Maintain current UTI prevention measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of clinically suspected UTI
Time (days) to recurrence of clinically suspected UTI
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start7 Jul 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UTI'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel allocation
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bonafide Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453693
- Sponsor's protocol ID
- BH-FOL-001
- Other IDs
- Study 13953
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Evaluating the Efficacy of the FLUSH Dietary Supplement Drink Mix to Improve Urinary Health Measures
- ClinicalTrials.gov ID
- NCT07453693
- Acronym / sponsor ID
- BH-FOL-001
- Conditions
- UTI's
- Keywords
- UTI, D-Mannose, Dietary Supplement, Urinary tract infections, Recurrent UTIs, Drink Mix
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Bonafide HealthIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled, parallel allocation
| Arm | Type | Receives |
|---|---|---|
| FLUSH Daily Dosing | Active comparator | Dietary Supplement: FLUSHDaily dosing of FLUSH |
| FLUSH 3-Day Dosing | Active comparator | Dietary Supplement: FLUSHDosing FLUSH once every 3 days and after sex if sexually active |
| Standard of Care | No intervention | –No study product administered. Maintain current UTI prevention measures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy biological females who are 18-75 years of age (inclusive).
- Have a history of recurrent uncomplicated UTI (≥2 UTIs in the last 6 months and/or ≥3 UTIs in the last 12 months).
- Are within 7 days of the enrollment trigger event (acute UTI).
- In good general health (no active or uncontrolled diseases or conditions besides recurrent UTIs) and able to consume the study product.
- BMI 18.5-39.9 kg/m^2
Key exclusion criteria (21 listed)
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Active participation in a clinical trial.
- Use of any treatment for menopausal outcomes or other concomitant treatments.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- History of hyperkalemia (high potassium).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUSH2g D-Mannose drink mix | Dietary supplement | FLUSH 3-Day Dosing, FLUSH Daily Dosing |
Primary outcome
Time to recurrence of clinically suspected UTI
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Proportion of Participants with ≥1 Clinically Suspected UTI
Time frame: 6 months
Proportion of Participants with ≥1 Culture-Proven UTI
Time frame: 6 months
Proportion of Participants with ≥1 Antibiotic-Treated UTI
Time frame: 6 months
Patient Global Impression of Severity (PGIS)
Time frame: 6 months
Product Experience Questionnaire (PEQ)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLUSH in people with UTI's, run by Bonafide Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence of clinically suspected UTI (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.