An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health Improvement
ConditionUTI's
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorBonafide Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FLUSH
Dietary supplement2g D-Mannose drink mix
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: FLUSH Daily DosingActive comparator 1 intervention
Group B: FLUSH 3-Day DosingActive comparator 1 intervention
Group C: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time to recurrence of clinically suspected UTI
Time (days) to recurrence of clinically suspected UTI
Time frame
6 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov