A Randomized, Controlled Trial Evaluating the Efficacy of the FLUSH Dietary Supplement Drink Mix to Improve Urinary Health Measures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Time to recurrence of clinically suspected UTI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FLUSH Daily Dosing
Daily dosing of FLUSH
干预措施: FLUSH (Dietary Supplement)
FLUSH 3-Day Dosing
Dosing FLUSH once every 3 days and after sex if sexually active
干预措施: FLUSH (Dietary Supplement)
Standard of Care
No study product administered. Maintain current UTI prevention measures.
结局指标
主要结局
Time to recurrence of clinically suspected UTI
时间窗: 6 months
Time (days) to recurrence of clinically suspected UTI
Symptom Severity as Measured by the Urinary Tract Infection Symptom Assessment Questionnaire (UTI-SIQ-8)
时间窗: 6 months
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.
Ratio of Good to Bad Urinary Health Days
时间窗: 6 months
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.
Patient Global Impression of Change (PGIC)
时间窗: 6 months
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.
Quality of Life as Measured by the Modified Recurrent Urinary Tract Infection Impact Questionnaire (m-RUTIIQ)
时间窗: 6 months
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.
Symptom Severity as Measured by the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), Section C
时间窗: 6 months
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.
次要结局
- 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)