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Completed

NCT Number: NCT01219595

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.

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sweetened, dried cranberries

Other

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

Other

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.

observation

Other

Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.

Primary outcomes

  1. Pre-treatment heterogeneity or prevalence

    Time frame: Day 1 - prior to start of study treatment

    • Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment

  2. Post-treatment heterogeneity

    Time frame: 2 weeks, 1 month, or 3 months

    • a change in the heterogeneity of strains post treatment

  3. Patient acceptance of study regimen

    Time frame: 2 weeks, 1 month, or 3 months

    • patient acceptance of the study regimen

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Ocean Spray Cranberries, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2010
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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