Randomised, Open-label, Controlled Clinical Trial to Evaluate the Efficacy of a Product Consisting of D Mannose 2 g+ Cran-max 500 mg+ Vitamin D3 0.001 mg (UROMANNOSA®) in Women With Recurrent Lower Urinary Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Number of symptomatic UTIs
研究概览
简要总结
To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI)
详细描述
Once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups:
Group A: Patients with repeat UTIs who will receive prophylactic treatment for 6 Months.
Group B: Patients with repeat UTIs who will receive prophylactic treatment for 3 Months.
Control group: Patients with recurrent UTIs who will not receive as prophylactic treatment the supplement under study.
The three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of Recurrent Lower Urinary Tract Infection (at least two episodes in the last 6 months or three episodes in the last 12 months).
- •Multiple infections must be spaced a minimum of 2 weeks apart or if less, with a negative urine culture in between.
- •Women who agree to participate and give their informed consent in writing
排除标准
- •Use of antibiotics or cranberry or other preventive treatment, pharmacological or not, for recurrence of urinary tract infections in the last two weeks.
- •Patient with indwelling catheter or intermittent catheterization.
- •Patients who present: Interstitial Cystitis, Neurogenic Bladder, Diabetes Mellitus, Nephrolithiasis, Cervical-Uterine Cancer diagnosed and treated less than 5 years ago.
- •Use of anticoagulants or contraceptive methods using spermicides or diaphragms.
- •Women consuming probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V.angustifolium (wild or lowbush blueberry), V. corymbosum ( highbush blueberry) or V. vitis-ideae (mountain blueberry), during the two weeks prior to recruitment.
- •High consumption of fruits rich in phenolic compounds, with special reference to berries.
- •Women allergic to berries
- •Pregnant or breastfeeding women.
结局指标
主要结局
Number of symptomatic UTIs
时间窗: Variable for each participant over course of up to one year
UTI Recurrence
时间窗: Variable for each participant over course of up to one year
Time (in days) from the start of treatment to the next episode of UTI
次要结局
未报告次要终点
研究者
Carmen Gonzalez Enguita
Staff Physician
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz