Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Frequency of UTIs
研究概览
简要总结
In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo.
The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo.
H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo.
H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months;
- •Laboratory urine culture: <103 CFUs
- •Age > 18 years
排除标准
- •UTIs ≥ 12 within 1 year
- •Pregnancy or Lactation
- •Immune disease
- •Lactose intolerance
- •Urinary tract anomaly
- •Systemic infection
- •Newly started hormone therapy within the last 6 months
- •Antibiotic prophylaxis within the last 6 months
- •α-D-mannose intake within the last month
- •Use of catheters
- •Diabetes mellitus
- •Participation to other studies
研究组 & 干预措施
placebo
2g Hänseler lactose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months. The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion.
rUTI diary
干预措施: Lactose (Drug)
mannose
2g d-mannose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months.The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion.
rUTI diary
干预措施: Mannose (Drug)
结局指标
主要结局
Frequency of UTIs
时间窗: 6 months
Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.
次要结局
- During UTI: Dysuria(during every UTI in the 6 months period)
- During UTI: Frequency(during every UTI in the 6 months period)
- During UTI: Flank (side) pain(during every UTI in the 6 months period)
- During UTI: Urgency(during every UTI in the 6 months period)
- During UTI: Cystalgia(during every UTI in the 6 months period)
- During UTI: Back pain(during every UTI in the 6 months period)
研究者
Gloria Ryu
Assistant medical director
Kantonsspital Aarau