Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 10
- 主要终点
- Time to onset of a first UTI within one year of treatment.
研究概览
简要总结
Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.
详细描述
Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections (UTI), leading to an important morbidity. Cranberry has been traditionally used for the treatment and prevention of UTI and research suggests that its mechanism of action is preventing bacterial adherence to host cell surface membrane.
However, systematic reviews show the small sample sizes and the poor quality of available trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
- •With an EDSS score ≥ 3
- •Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
- •Ambulatory at inclusion
- •Able to undergo evaluation
- •Informed written consent
- •Non-inclusion Criteria:
- •Regular consumption of cranberry within 3 months before inclusion
- •Symptomatic urinary tract infection at inclusion
- •Chronic renal failure (creatinin clearance < 10ml/min)
- •Patients with urinary permanent catheterization
- •Patients with hyperuricemia and risk of uric acid lithiasis
- •Patients with oral anticoagulant treatment (antivitamins K)
- •Peptic ulcer
- •Intolerance to cranberry and/or excipients
- •Urinary tract infections antibioprophylaxis
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Cranberry
Cranberry
干预措施: Cranberry (Drug)
结局指标
主要结局
Time to onset of a first UTI within one year of treatment.
时间窗: one year
次要结局
- Rate of patients with at least one UTI during the one-year treatment(Determined at M3, M6, M9 and M12)
- Number of UTI(Determined at M3, M6, M9 and M12)
- Score on Qualiveen® scale(Determined at M3, M6, M9 and M12)
- Symptomatology of urinary disorders(Determined at M3, M6, M9 and M12)
- EDSS score(Determined at M3, M6, M9 and M12)
- Number of multiple sclerosis attacks(Determined at M3, M6, M9 and M12)
- Antibiotics consumption(Determined at M3, M6, M9 and M12)
- Safety of cranberry(Determined at M3, M6, M9 and M12)
- Patients' observance to treatment(Determined at M3, M6, M9 and M12)