Urinary Tract Infection
Conditions
Keywords
Urinary Tract Infection, UTI
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.
Interventions
OTHERSweetened, dried cranberries
Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
OTHERStrawberry 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.
OTHERObservation
Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.
Sponsors
Ocean Spray Cranberries, Inc.
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
| Measure the UTI recurrence | 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 | 2 weeks, 1 month, or 3 months | Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces) |
Countries
United States
Outcome results
None listed