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

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219595
• Other study ID #: H-2010-0107
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

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