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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01219595
Other study ID # H-2010-0107
Secondary ID
Status Completed
Phase N/A
First received October 8, 2010
Last updated January 28, 2016
Start date September 2010
Est. completion date September 2012

Study information

Verified date January 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 65
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Intervention

Other:
Sweetened, dried cranberries
Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
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.
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.
Sweetened, dried cranberries
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Strawberry Fruit Pieces
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
Observation
Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.

Locations

Country Name City State
United States University of Wisconsin-Madison Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Ocean Spray Cranberries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Post-treatment heterogeneity 2) a change in the heterogeneity of strains post treatment 2 weeks, 1 month, or 3 months No
Primary Patient acceptance of study regimen 3) patient acceptance of the study regimen 2 weeks, 1 month, or 3 months No
Primary 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 No
Primary 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 No
Primary 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 No
Primary Measure the UTI recurrence Measure the UTI recurrence after 6 months from the beginning of the study. 2 weeks, 1 month, or 3 months No
Primary 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 No
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