Clinical trial NCT01219595: Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
Official title: Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Urinary Tract Infection
UTI
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Ocean Spray Cranberries, Inc.
First posted: 2010-10-13
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre-treatment heterogeneity or prevalence
timeFrame: Day 1 - prior to start of study treatment
measure: Post-treatment heterogeneity
timeFrame: 2 weeks, 1 month, or 3 months
measure: Patient acceptance of study regimen
timeFrame: 2 weeks, 1 month, or 3 months
measure: Maintenance of heterogeneity in the intestinal flora
timeFrame: Approximately 3 months
measure: Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
timeFrame: Approximately 3 months
measure: Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
timeFrame: 2 weeks, 1 month, or 3 months
measure: Measure the UTI recurrence
timeFrame: 2 weeks, 1 month, or 3 months
measure: Comparison of sweetened dried cranberries to a placebo group
timeFrame: 2 weeks, 1 month, or 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Walter Hopkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: