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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01219595
First Posted: October 13, 2010
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ocean Spray Cranberries, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention
Urinary Tract Infection Other: Sweetened, dried cranberries Other: Strawberry Fruit Pieces Other: Observation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Pre-treatment heterogeneity or prevalence [ Time Frame: 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 [ Time Frame: 2 weeks, 1 month, or 3 months ]
    2) a change in the heterogeneity of strains post treatment

  • Patient acceptance of study regimen [ Time Frame: 2 weeks, 1 month, or 3 months ]
    3) patient acceptance of the study regimen

  • Maintenance of heterogeneity in the intestinal flora [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 weeks, 1 month, or 3 months ]
    Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure

  • Measure the UTI recurrence [ Time Frame: 2 weeks, 1 month, or 3 months ]
    Measure the UTI recurrence after 6 months from the beginning of the study.

  • Comparison of sweetened dried cranberries to a placebo group [ Time Frame: 2 weeks, 1 month, or 3 months ]
    Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)


Enrollment: 65
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219595


Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Ocean Spray Cranberries, Inc.
Investigators
Principal Investigator: Walter Hopkins, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01219595     History of Changes
Other Study ID Numbers: H-2010-0107
First Submitted: October 8, 2010
First Posted: October 13, 2010
Last Update Posted: January 29, 2016
Last Verified: January 2016

Keywords provided by University of Wisconsin, Madison:
Urinary Tract Infection
UTI

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Proanthocyanidin
Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents