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临床试验/NCT05065008
NCT05065008进行中(未招募)不适用

Investigate the Roles of Gut Microbiome in the Differential Responses of UTI Susceptible Women to Cranberry Juice Intake

University of Florida2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
160
试验地点
2
主要终点
Change in the unrinary anti-adhesion activity of UTI susceptible women

研究概览

简要总结

Clinical trials on cranberry juice and UTI prevention yielded both positive and negative results for unknown reason. Gut microbiome in women affect the absorption and metabolism of cranberry bioactives. The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention in women.

详细描述

The American cranberries, especially cranberry juice, have used for centuries as a folk medicine to prevent urinary tract infections (UTI), which affect 50% of women in their lifetime. Over 40 clinical trials have been conducted in the last 20 years to verify the UTI preventatively activity of cranberry juices, but the results were contradictory. About 90% of UTI are initiated by the adhesion of uropathogenic E. coli (UPEC) on urinary tract epithelia. It was reported that human urine after consumption of cranberry juice inhibited the adhesion of UPEC. The A-type proanthocyanidins and xyloglucans are the presumed bioactives in cranberries, however, this is unlikely because these two classes of compounds have extremely low bioavailability in human body. Preliminary research suggested that women can be either "resistant" or "susceptible" to UTI depending on the inherent anti-adhesion activity in their urine against UPEC before consuming cranberry juice. Not all but a fraction of "UTI susceptible" women had increased urinary anti-adhesion activity after consuming cranberry juices. These women are classified as "responders" and others are "non-responders". The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention. The objective of this trials is to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of UPEC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

入选标准

  • Healthy women participants;
  • BMI 18.5-29.9 kg/m2;
  • At least 110 pounds in weight

排除标准

  • BMI≥ 30 kg/m2;
  • Pregnancy and breast-feeding;
  • Smoking, frequent alcohol use;
  • History of any clinically important disorder that may interfere with interpretation of the results;
  • Intake of medication that might influence the outcome of the study

结局指标

主要结局

Change in the unrinary anti-adhesion activity of UTI susceptible women

时间窗: Baseline up to 21 days of each intervention

Compare the statistical differences between the changes from baseline in the an-adhesion activity against uropathogenic E. coli in UTI-susceptible women after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks. Anti-adhesion activity in urine will be measured using a fluorescence-based microplate method. The anti-adhesion activities of urines will be expressed by its equivalence to myricetin level. The unit for urine anti-adhesion activities is µg myricetin/mg creatinine.

次要结局

  • Identify anti-adhesion urinary biomarkers in responders versus non-responders after the cranberry juice intake(Baseline upt to 21 days of each intervention)
  • Determine the compositional differences of gut microbiome in responders and non-responders after the cranberry juice intake(Baseline up to 21 days of each intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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