Efficacy of a Food Supplement for the Treament of Recurrent Urinary Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Recurrence of Urninary Tract Infections (UTIs)
研究概览
简要总结
Randomized clinical trial to evaluate the effect of a probiotic mixture of Lactobacillus plantarum on recurrent urinary tract infections in women. Secondary outcomes comprise variation in vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
详细描述
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of Lactobacillus plantarum on recurrent urinary tract infections in women. Women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of Lactobacillus plantarum in combination with cranberry, and vitamine C; and the other group will receive a capsule of placebo for 6 months. Main study outcome is the number of women who have recurrence of UTIs during th estudy compared to the placebo group. Secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic UTIs during the study, variation of Lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
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)
盲法说明
Probiotic and placebo products will be provided in identical packaging
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 18 years of age.
- •Women who have had at least one episode of UTI in the past 4 months
- •Women with a well-documented history of recurrent UTIs: ≥2 infections in the past 6 months or ≥3 in the past 12 months.
- •Women who have been treated with an antibiotic regimen for each episde of UTI
- •Recurrence due to reinfection, not relapse: multiple infections should be spaced by a minimum of 2 weeks or in case of a shorter time, with negative urine culture between them
- •Women who use contraception to prevent pregnancy and who do not plan a pregnancy during the study period
排除标准
- •Pregnant or breastfeeding women
- •Underlying chronic disease: diabetes mellitus, kidney failure, cancer, spinal cord injury, polycystic ovary
- •Women wih catheters in the urethra
- •Women who consume 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 low buch blueberry), V. corymbosum (tall bch blueberry) or V. vitis-ideae (mountain blueberry) during the 2 weels prior to recruitment.
- •High consumption of fruits rich in phenolic compounds, with special reference, to berries
- •Women allergic to red fruits
研究组 & 干预措施
Experimental
Probiotic formulation comprising Lactobacillus plantarum CECT8675 and CECT8677 in combination with cranberry, and vitamine C in a capsule format. Probiotic strains have Qualified Presumption of Safety (QPS) sttus by European Food Safety Authority.
干预措施: Food supplement (Dietary Supplement)
Placebo
Placebo composed of maltodextrin
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Recurrence of Urninary Tract Infections (UTIs)
时间窗: month 6
Number of women who have recurrence of UTIs
次要结局
- Total symptomatic UTIs number(month 6)
- Change in UTI symptomatology(baseline, month 6)
- Incidence of Treatment-Emergent Adverse Events(From baseline until month 6)
- Change in Microbiota(baseline, month 6)
- Time without UTI(month 6)
- Satisfaction with the product(Month 6)