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

Official title

A Randomized, Controlled Trial Evaluating the Efficacy of the FLUSH Dietary Supplement Drink Mix to Improve Urinary Health Measures

Overview

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 supplement FLUSH
  2g D-Mannose drink mix

Primary outcome measures

• Time to recurrence of clinically suspected UTI [Time frame: 6 months]
• Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8) [Time frame: 6 months]
• Ratio of Good to Bad Urinary Health Days [Time frame: 6 months]
• Patient Global Impression of Change (PGIC) [Time frame: 6 months]
• Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ) [Time frame: 6 months]
• Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C [Time frame: 6 months]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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.

Exclusion criteria

• 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).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Bonafide Health — Harrison

Identifiers

NCT: NCT07453693 · BH-FOL-001 · Study 13953

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗