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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

Conditions
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Bacteriuria

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Cranberry Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3 placebo capsules<br>3 placebo capsules qd | Dietary Supplement: Placebo<br>* 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).<br>|
| Experimental: 1 cranberry capsule & 2 placebo capsules<br>1 active cranberry capsule and 2 placebo capsules qd | Dietary Supplement: Placebo<br>* 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).<br>Dietary Supplement: Cranberry Capsule<br>* 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).<br>* Other names: Ellura;|
| Experimental: 2 cranberry capsules & 1 placebo capsule<br>2 active cranberry capsules and 1 placebo capsules qd | Dietary Supplement: Placebo<br>* 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).<br>Dietary Supplement: Cranberry Capsule<br>* 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).<br>* Other names: Ellura;|
| Experimental: 3 cranberry capsules<br>3 active cranberry capsules qd | Dietary Supplement: Cranberry Capsule<br>* 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).<br>* Other names: Ellura;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | one month |