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:
Collaborator:
Ocean Spray Cranberries, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01219595
First received: October 8, 2010
Last updated: June 25, 2014
Last verified: June 2014
  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 Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    2) a change in the heterogeneity of strains post treatment

  • Patient acceptance of study regimen [ Time Frame: 2 weeks, 1 month, or 3 months ] [ Designated as safety issue: No ]
    3) patient acceptance of the study regimen

  • Maintenance of heterogeneity in the intestinal flora [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)


Enrollment: 70
Study Start Date: September 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01219595     History of Changes
Other Study ID Numbers: H-2010-0107
Study First Received: October 8, 2010
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014