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

NCT07453693 | Recruiting

• 2 other identifiers: BH-FOL-001Study 13953
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

UTI's

Keywords

UTI; D-Mannose; Dietary Supplement; Urinary tract infections; Recurrent UTIs; Drink Mix

Outcome Measures

Primary Outcomes (6)

• Time to recurrence of clinically suspected UTI

  Time (days) to recurrence of clinically suspected UTI

  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.

  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.

  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.

  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.

  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.

  6 months

Secondary Outcomes (5)

• Proportion of Participants with ≥1 Clinically Suspected UTI

  6 months

• Proportion of Participants with ≥1 Culture-Proven UTI

  6 months

• Proportion of Participants with ≥1 Antibiotic-Treated UTI

  6 months

• Patient Global Impression of Severity (PGIS)

  6 months

• Product Experience Questionnaire (PEQ)

  6 months

Study Arms (3)

FLUSH Daily Dosing

ACTIVE COMPARATOR

Daily dosing of FLUSH

Dietary Supplement: FLUSH

FLUSH 3-Day Dosing

ACTIVE COMPARATOR

Dosing FLUSH once every 3 days and after sex if sexually active

Dietary Supplement: FLUSH

Standard of Care

NO INTERVENTION

No study product administered. Maintain current UTI prevention measures.

Interventions

FLUSH DIETARY_SUPPLEMENT

2g D-Mannose drink mix

FLUSH 3-Day Dosing; FLUSH Daily Dosing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Bonafide Health: lead

Study Sites (1)

Bonafide Health

Harrison, New York, 10528, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, parallel allocation

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 6, 2026
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)