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

University of Wisconsin (UW)

Status

Completed

Conditions

Urinary Tract Infection

Treatments

Other: Strawberry Fruit Pieces

Other: Sweetened, dried cranberries

Other: Observation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01219595

H-2010-0107

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

65 participants in 6 patient groups, including a placebo group

Part 1

Active Comparator group

Description:

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

Treatment:

Other: Sweetened, dried cranberries

No treatment

Other group

Description:

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

Treatment:

Other: Observation

Part 2A

Active Comparator group

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.

Treatment:

Other: Sweetened, dried cranberries

Part 2B

Placebo Comparator group

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.

Treatment:

Other: Strawberry Fruit Pieces

Part 3A

Active Comparator group

Description:

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

Treatment:

Other: Sweetened, dried cranberries

Part 3B

Placebo Comparator group

Description:

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