Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Pre-treatment heterogeneity or prevalence
研究概览
简要总结
The purpose of the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in susceptible women.
详细描述
This is a research study about the number and types of bacteria that cause urinary tract infections (E. coli strains) that are present in the intestine. The bacteria will be collected and analyzed before and after eating either sweetened, dried cranberries or strawberry fruit pieces. This study will help us learn more about whether or not the components of consumed sweetened, dried cranberries or strawberry fruit pieces reduce the numbers of harmful E. coli bacteria in the vaginal and intestinal tracts, thereby reducing the number of urinary tract infections among women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, ages 18-65
- •History of recurrent urinary tract infections defined as three in the past year, or two in the last six months
- •Subjects must be willing to follow the study protocol that includes consuming the mandatory daily dose of cranberries or strawberry fruit pieces and traveling to the UWHC Urology clinic for scheduled rectal and vaginal swab procedures.
- •The non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
排除标准
- •Are pregnant
- •Have an immune compromising disease
- •Have diabetes
- •Have kidney stones
- •Have chronic bowel inflammatory disease
- •Have known allergies to cranberries, strawberries, elderberries, or wheat fiber
- •Non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
研究组 & 干预措施
Part 1
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
干预措施: Sweetened, dried cranberries (Other)
No treatment
20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women.
干预措施: Observation (Other)
Part 2A
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.
干预措施: Sweetened, dried cranberries (Other)
Part 2B
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.
干预措施: Strawberry Fruit Pieces (Other)
Part 3A
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
干预措施: Sweetened, dried cranberries (Other)
Part 3B
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
干预措施: Strawberry Fruit Pieces (Other)
结局指标
主要结局
Pre-treatment heterogeneity or prevalence
时间窗: Day 1 - prior to start of study treatment
1\) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment
Post-treatment heterogeneity
时间窗: 2 weeks, 1 month, or 3 months
2\) a change in the heterogeneity of strains post treatment
Patient acceptance of study regimen
时间窗: 2 weeks, 1 month, or 3 months
3\) patient acceptance of the study regimen
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
时间窗: 2 weeks, 1 month, or 3 months
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
时间窗: Approximately 3 months
Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Maintenance of heterogeneity in the intestinal flora
时间窗: Approximately 3 months
To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.
Measure the UTI recurrence
时间窗: 2 weeks, 1 month, or 3 months
Measure the UTI recurrence after 6 months from the beginning of the study.
Comparison of sweetened dried cranberries to a placebo group
时间窗: 2 weeks, 1 month, or 3 months
Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)
次要结局
未报告次要终点