Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
- Conditions
- Urinary Tract Infection
- Interventions
- Other: ObservationOther: Sweetened, dried cranberriesOther: Strawberry Fruit Pieces
- Registration Number
- NCT01219595
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
- 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.
Women who:
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description No treatment Observation 20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women. Part 2A Sweetened, dried cranberries 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. Part 2B Strawberry Fruit Pieces 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. Part 3A Sweetened, dried cranberries 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. Part 3B Strawberry Fruit Pieces 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. Part 1 Sweetened, dried cranberries 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
- Primary Outcome Measures
Name Time Method Measure the UTI recurrence 2 weeks, 1 month, or 3 months Measure the UTI recurrence after 6 months from the beginning of the study.
Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures Approximately 3 months Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Pre-treatment heterogeneity or prevalence 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 2 weeks, 1 month, or 3 months 2) a change in the heterogeneity of strains post treatment
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure 2 weeks, 1 month, or 3 months Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Patient acceptance of study regimen 2 weeks, 1 month, or 3 months 3) patient acceptance of the study regimen
Maintenance of heterogeneity in the intestinal flora Approximately 3 months To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.
Comparison of sweetened dried cranberries to a placebo group 2 weeks, 1 month, or 3 months Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States