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

University of Wisconsin, Madison2 sites in 1 country65 target enrollmentStarted: September 2010Last updated: January 29, 2016

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: University of Wisconsin, Madison
Enrollment: 65
Locations: 2
Primary Endpoint: Pre-treatment heterogeneity or prevalence

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Basic Science
Masking: Single (Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: Female
Accepts 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

•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.

Outcomes

Primary Outcomes

Pre-treatment heterogeneity or prevalence

Time Frame: Day 1 - prior to start of study treatment

1\) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment

Maintenance of heterogeneity in the intestinal flora

Time Frame: 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

Time Frame: 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