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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка FLUSH
  2g D-Mannose drink mix

Первичные конечные точки

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

Вторичные конечные точки (5)

• Proportion of Participants with ≥1 Clinically Suspected UTI [Срок оценки: 6 months]
• Proportion of Participants with ≥1 Culture-Proven UTI [Срок оценки: 6 months]
• Proportion of Participants with ≥1 Antibiotic-Treated UTI [Срок оценки: 6 months]
• Patient Global Impression of Severity (PGIS) [Срок оценки: 6 months]
• Product Experience Questionnaire (PEQ) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Bonafide Health — Harrison

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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