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

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sweetened, dried cranberries
Strawberry Fruit Pieces
Sweetened, dried cranberries
Sweetened, dried cranberries
Strawberry Fruit Pieces
Observation
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Tract Infection focused on measuring Urinary Tract Infection, UTI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Other

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Part 1

No treatment

Part 2A

Part 2B

Part 3A

Part 3B

Arm Description

1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.

20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women.

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.

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.

1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.

1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.

Outcomes

Primary Outcome Measures

Pre-treatment heterogeneity or prevalence
1) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment
Post-treatment heterogeneity
2) a change in the heterogeneity of strains post treatment
Patient acceptance of study regimen
3) patient acceptance of the study regimen
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.
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
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
Measure the UTI recurrence
Measure the UTI recurrence after 6 months from the beginning of the study.
Comparison of sweetened dried cranberries to a placebo group
Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)

Secondary Outcome Measures

Full Information

First Posted
October 8, 2010
Last Updated
January 28, 2016
Sponsor
University of Wisconsin, Madison
Collaborators
Ocean Spray Cranberries, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01219595
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Ocean Spray Cranberries, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Urinary Tract Infection, UTI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1
Arm Type
Active Comparator
Arm Description
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
Arm Title
No treatment
Arm Type
Other
Arm Description
20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women.
Arm Title
Part 2A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Part 2B
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Part 3A
Arm Type
Active Comparator
Arm Description
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Arm Title
Part 3B
Arm Type
Placebo Comparator
Arm Description
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
Intervention Type
Other
Intervention Name(s)
Sweetened, dried cranberries
Intervention Description
Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
Intervention Type
Other
Intervention Name(s)
Strawberry Fruit Pieces
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sweetened, dried cranberries
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sweetened, dried cranberries
Intervention Description
1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
Intervention Type
Other
Intervention Name(s)
Strawberry Fruit Pieces
Intervention Description
1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.
Primary Outcome Measure Information:
Title
Pre-treatment heterogeneity or prevalence
Description
1) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment
Time Frame
Day 1 - prior to start of study treatment
Title
Post-treatment heterogeneity
Description
2) a change in the heterogeneity of strains post treatment
Time Frame
2 weeks, 1 month, or 3 months
Title
Patient acceptance of study regimen
Description
3) patient acceptance of the study regimen
Time Frame
2 weeks, 1 month, or 3 months
Title
Maintenance of heterogeneity in the intestinal flora
Description
To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.
Time Frame
Approximately 3 months
Title
Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Description
Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures
Time Frame
Approximately 3 months
Title
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Description
Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure
Time Frame
2 weeks, 1 month, or 3 months
Title
Measure the UTI recurrence
Description
Measure the UTI recurrence after 6 months from the beginning of the study.
Time Frame
2 weeks, 1 month, or 3 months
Title
Comparison of sweetened dried cranberries to a placebo group
Description
Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)
Time Frame
2 weeks, 1 month, or 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Hopkins, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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