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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Other: Sweetened, dried cranberries; Other: Sweetened, dried cranberries; Other: Sweetened, dried cranberries; Other: Observation; Other: Strawberry Fruit Pieces; Other: Strawberry Fruit Pieces

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Part 1; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.	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.; Other: 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.; Other: Sweetened, dried cranberries; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Other: No treatment; 20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women.	Other: Observation; Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.
Active Comparator: Part 2A; 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.	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.; Other: 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.; Other: Sweetened, dried cranberries; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Placebo Comparator: Part 2B; 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.	Other: 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.; Other: Strawberry Fruit Pieces; 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
Active Comparator: Part 3A; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.	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.; Other: 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.; Other: Sweetened, dried cranberries; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Placebo Comparator: Part 3B; 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.	Other: 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.; Other: Strawberry Fruit Pieces; 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Ocean Spray Cranberries, Inc.
• Investigators: Principal Investigator: Walter Hopkins, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Urinary Tract Infection; UTI
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: H-2010-0107