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| Name | Class |
|---|---|
| Ocean Spray Cranberries, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Active Comparator | 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks. |
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| No treatment | Other | 20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women. |
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| Part 2A | Active Comparator | 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. |
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| Part 2B | Placebo Comparator | 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. |
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| Part 3A | Active Comparator | 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sweetened, dried cranberries | Other | Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks. |
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| 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. |
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Inclusion Criteria:
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:
Non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
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| Name | Affiliation | Role |
|---|---|---|
| Walter Hopkins, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
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| Part 3B |
| Placebo Comparator |
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. |
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| Strawberry Fruit Pieces | Other | 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. |
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| Sweetened, dried cranberries | Other | 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. |
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| Sweetened, dried cranberries | Other | 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period. |
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| Strawberry Fruit Pieces | Other | 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period. |
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| Observation | Other | Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected. |
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| 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 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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