RecruitingNot Applicable

An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement

United States210 participantsStarted 2025-07-07

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to recurrence of clinically suspected UTI

Timeframe: 6 months

Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8)

Timeframe: 6 months

Ratio of Good to Bad Urinary Health Days

Timeframe: 6 months

Patient Global Impression of Change (PGIC)

Timeframe: 6 months

Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ)

Timeframe: 6 months

Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C

Timeframe: 6 months

Trial details

NCT IDNCT07453693

SponsorBonafide Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-15

View on ClinicalTrials.gov More UTI's trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

Time to recurrence of clinically suspected UTI

Timeframe: 6 months

Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8)

Timeframe: 6 months

Ratio of Good to Bad Urinary Health Days

Timeframe: 6 months

Patient Global Impression of Change (PGIC)

Timeframe: 6 months

Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ)

Timeframe: 6 months

Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C

Timeframe: 6 months

An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria