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

Not Applicable

Completed

• Conditions: Urinary Tract Infection

• Registration Number: NCT01219595
• Lead Sponsor: University of Wisconsin, Madison

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measure the UTI recurrence	2 weeks, 1 month, or 3 months	Measure the UTI recurrence after 6 months from the beginning of the study.
Pre-treatment heterogeneity or prevalence	Day 1 - prior to start of study treatment	1) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment
Post-treatment heterogeneity	2 weeks, 1 month, or 3 months	2) a change in the heterogeneity of strains post treatment
Patient acceptance of study regimen	2 weeks, 1 month, or 3 months	3) patient acceptance of the study regimen
Maintenance of heterogeneity in the intestinal flora	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	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	2 weeks, 1 month, or 3 months	Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Comparison of sweetened dried cranberries to a placebo group	2 weeks, 1 month, or 3 months	Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States