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临床试验/NCT02572895
NCT02572895Unknown1 期

Recurrent Urinary Tract Infection Prevention With Biologic Cranberry Extract Intake Standardized in Proanthocyanidins: A Double-blind Clinical Trial

Laval University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
1 期
入组人数
140
试验地点
2
主要终点
Mean number of urinary tract infections

研究概览

简要总结

The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.

详细描述

Cranberry juice, fruit (fresh and dried), functional foods, and cranberry dietary supplements are promoted for prevention of urinary tract infections (UTIs) on the basis of their content of cranberry proanthocyanidins (PACs) with "A-type" interflavan bonds. Several clinical trials have assessed efficacy of cranberry-derived products, essentially with cranberry juices, but discordant results have been found. Lack of compliance but mostly lack of standardization in product concentrations can account for the variability among results. Indeed, most clinical trials do not report quantity of PACs. According to most recent studies, quantification of PACs requiring standardized and reproducible methods should be at least 37 mg/day. It can be hypothesized that efficacy of cranberry extract in UTIs prevention among young women can be strongly increased using optimal dosage (standardized to 37 mg/day of PACs). The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent UTIs, efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of PACs, compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy and sexually active women
  • Aged between 18 to 45 years old
  • Recurrence of 2 UTIs in the past 6 months or 3 in the past year
  • Do not have consumed cranberry juice, polyphenols or antioxidant supplements in the last 2 weeks
  • Internet access

排除标准

  • Women who have personal history of acute or chronic renal failure
  • Women who have personal history of urogenital system anomalies, urogenital tractus surgery or intestinal diseases causing malabsorption (e.g., Crohn and celiac diseases)
  • Women who have personal history of kidney stones, taking anticoagulant medication or have taken anticoagulant medication in the last month
  • Women presenting cranberry allergy or intolerance

结局指标

主要结局

Mean number of urinary tract infections

时间窗: Within a 6-month period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Dodin

MD, M.Sc.

Laval University

研究点 (2)

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