Preventive Effect of Aronia Mixture Against UTI - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Study feasibility: recruitment of participants
研究概览
简要总结
The goal is to determine the feasibility of conducting a randomised clinical trial to measure the effectiveness of an aronia mixture in reducing recurrence of urinary tract infections (UTIs) and antibiotic use by women with a history of frequent UTIs. In addition, the study aim to collect data in order to establish power calculations required for a full-scale study.
详细描述
Aronia berries have been and are used as a food, especially in Eastern Europe and the USA. No negative health effects have been reported from consuming similar amounts of aronia berries as those given to participants in this pilot study. On the contrary, studies suggest that consuming aronia berries has several positive health effects (1). The present 6-months pilot study will examine the feasibility of the study (recruitment process, drop-outs, program adherence, treatment duration, program accetability), identify potential biomarkers of the aronia-mixture and provide information to establish power calculations in a full-scale randomized controlled trial.
Outcomes in the pilot study is number of UTI episodes (both treated and untreated) corresponding to historical episodes (last 12 months), characterization of uropathogens from urine culture analyses, as well as characterization of phenolic metabolites in urine as a result of the intervention. Findings of catabolites based on certain polyphenols will reflect the intestinal ability to metabolize compounds (e.g. condensed tannins), and how these catabolites are absorbed into the circulatory system. Changes in the catabolite pattern will form the basis for estimation of the intervention period needed when planning a full-scale randomized controlled trial.
Research Team:
Tonje H Stea (Professor, University of Agder) - Project Leader Rune Slimestad (Chemist, PhD PlantChem AS) - Responsible for metabolite analysis of urine. Will provide intervention drink and urine containers to the medical office.
Nils Grude (Senior Physician, PhD Antibiotic Center, Ullevål Hospital) - Responsible for microbiology expertise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •More than 18 years old
- •Recurrent urinary tract infections (rUTI) (minimum of 2 episodes in the last 6 months, or minimum of 3 episodes in the last 12 months).
- •Participants should be cooperative, capable of maintaining a patient diary, and providing urine samples according to a specified schedule.
排除标准
- •Use of Hiprex in the last 6 months.
- •Regular use of aronia in the last 6 months.
- •Allergy to heat-treated aronia or apple.
- •Uncontrolled diabetes mellitus.
- •Use of blood-thinning medication (e.g. Warfarin).
结局指标
主要结局
Study feasibility: recruitment of participants
时间窗: From enrollment to end of treatment at 6 months
Experiences related to the process of recruiting study participants
Study feasibility: drop-outs
时间窗: From enrollment to end of treatment at 6 months
Register the number of dropouts during the intervention period
Study feasibility: program adherence
时间窗: From enrollment to end of treatment at 6 months
Examine adherence to the program by study participants and staff
Study feasibility: duration of the intervention period
时间窗: From enrollment to end of treatment at 6 months
Acceptance of treatment duration among participants and recruiters
次要结局
- Number of Urinary Tract Infections (UTIs) during the intervention period(From enrollment to end of treatment at 6 months)
研究者
Tonje Holte Stea
Professor
University of Agder