Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

Yale University80 enrolled

Overview

This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. The Yale research team will be enrolling 80 subjects in total over several nursing home locations within Connecticut.

Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Bacteriuria

Interventions

PlaceboDIETARY_SUPPLEMENT

36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).

Cranberry CapsuleDIETARY_SUPPLEMENT

36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).

Eligibility

Sex: FEMALEMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year. Exclusion Criteria: * residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal \[life expectancy \< 1 month\]); * residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI; * residents with end stage renal disease on dialysis (they do not regularly produce urine); * residents unable to produce a baseline clean catch urine specimen for collection; * residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice; * residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.

Locations (14)

Northbridge Health Care Center

Bridgeport, Connecticut, United States

Sheriden Woods Health Care Center

Bristol, Connecticut, United States

Outcomes

Primary Outcomes

E.Coli Bacteriuria Plus Pyuria

The number of urine cultures and urinalyses (obtained weekly) found with \>100,000 CFU/ml growth of E.coli and \>10 WBC.

Time frame: One month

Secondary Outcomes

Other Bacteriuria Plus Pyuria

The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) \>100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.

Time frame: one month

Not Growth

The number of not growth, these include no growth, growth \<100,000 CFU/ml, growth \>100,000 CFU/ml but no WBCs, and mixed flora.

Time frame: one month

Data from ClinicalTrials.gov

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