Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Other: Sweetened, dried cranberries
* Other: Strawberry Fruit Pieces
* Other: Sweetened, dried cranberries
* Other: Sweetened, dried cranberries
* Other: Strawberry Fruit Pieces
* Other: Observation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part 1<br>1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks. | Other: Sweetened, dried cranberries<br>* Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.<br>Other: Sweetened, dried cranberries<br>* 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.<br>Other: Sweetened, dried cranberries<br>* 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.<br>|
| Other: No treatment<br>20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women. | Other: Observation<br>* Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.<br>|
| Active Comparator: Part 2A<br>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. | Other: Sweetened, dried cranberries<br>* Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.<br>Other: Sweetened, dried cranberries<br>* 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.<br>Other: Sweetened, dried cranberries<br>* 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.<br>|
| Placebo Comparator: Part 2B<br>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. | Other: Strawberry Fruit Pieces<br>* 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.<br>Other: Strawberry Fruit Pieces<br>* 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.<br>|
| Active Comparator: Part 3A<br>1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. | Other: Sweetened, dried cranberries<br>* Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.<br>Other: Sweetened, dried cranberries<br>* 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.<br>Other: Sweetened, dried cranberries<br>* 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.<br>|
| Placebo Comparator: Part 3B<br>1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. | Other: Strawberry Fruit Pieces<br>* 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.<br>Other: Strawberry Fruit Pieces<br>* 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-treatment heterogeneity or prevalence | 1) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment | Day 1 - prior to start of study treatment | 
| Post-treatment heterogeneity | 2) a change in the heterogeneity of strains post treatment | 2 weeks, 1 month, or 3 months | 
| Patient acceptance of study regimen | 3) patient acceptance of the study regimen | 2 weeks, 1 month, or 3 months | 
| Maintenance of heterogeneity in the intestinal flora | To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period. | 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 three two-week exposures | Approximately 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 one 4-week exposure | 2 weeks, 1 month, or 3 months | 
| Measure the UTI recurrence | Measure the UTI recurrence after 6 months from the beginning of the study. | 2 weeks, 1 month, or 3 months | 
| Comparison of sweetened dried cranberries to a placebo group | Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces) | 2 weeks, 1 month, or 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Infection, UTI