EFFICACIA DI UN INTEGRATORE A BASE DI D-MANNOSIO, PROPOLI, QUERCETINA, COLLAGENE E BACILLUS COAGULANS NEL RIDURRE L'INCIDENZA E MIGLIORARE LA QUALITA' DI VITA IN DONNE CON CISTITE RICORRENTE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Number of urinary tract infections per month
研究概览
简要总结
The aim of this study is to evaluate whether a dietary supplement based on D-mannose, collagen, hyaluronic acid, chondroitin sulphate, enhanced by the properties of quercetin plus propolis (Proqutin ®) and Bacillus Coagulans, eventually associated with antimicrobial prophylaxis, could be effective in preventing recurrent UTIs and improving related quality of life.
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
- Single (Participant)
盲法说明
Participants are blind to treatment arm
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a history of rUTIs (defined by EAU guidelines as a frequency of at least three UTIs per year, or two UTIs in the past six months in the last 12 months, confirmed by positive urine cultures
- •not undergone any previous treatment for their condition.
排除标准
- •age under or over limit
- •concurrent antimicrobial treatment
- •any ongoing treatment that could influence study outcomes,
- •congenital or post-surgical urinary tract anomalies
- •immunodeficiency or HIV infection
- •ongoing pregnancy.
研究组 & 干预措施
Group A
干预措施: Fosfomycin 3 g (Drug)
Group B
Dietary supplement of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.
干预措施: Uroxin 4G (Dietary Supplement)
Group C
Combination of treatment A and B
干预措施: Combination of dietary supplement and fosfomycin (Drug)
结局指标
主要结局
Number of urinary tract infections per month
时间窗: 6 and 12 months
次要结局
- ICIQ-FLUTS scores(6 and 12 months)
- Number of women matching recurrent urinary tract infection criteria(12 months)
研究者
Gaetano Riemma
Principal investigator
University of Campania "Luigi Vanvitelli"