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

Phase 1

Completed

Interventions: Dietary Supplement: Placebo
Dietary Supplement: Cranberry Capsule

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
3 placebo capsules	Placebo	3 placebo capsules qd
1 cranberry capsule & 2 placebo capsules	Placebo	1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules	Cranberry Capsule	1 active cranberry capsule and 2 placebo capsules qd
2 cranberry capsules & 1 placebo capsule	Placebo	2 active cranberry capsules and 1 placebo capsules qd
2 cranberry capsules & 1 placebo capsule	Cranberry Capsule	2 active cranberry capsules and 1 placebo capsules qd
3 cranberry capsules	Cranberry Capsule	3 active cranberry capsules qd

Primary Outcome Measures

Name	Time	Method
E.Coli Bacteriuria Plus Pyuria	One month	The number of urine cultures and urinalyses (obtained weekly) found with \>100,000 CFU/ml growth of E.coli and \>10 WBC.

Secondary Outcome Measures

Name	Time	Method
Other Bacteriuria Plus Pyuria	one month	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.
Not Growth	one month	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.

Locations (14): Sheriden Woods Health Care Center
🇺🇸
Bristol, Connecticut, United States
Abbott Terracee Health Center
🇺🇸
Waterbury, Connecticut, United States
Wadsworth Glen Health Care and Rehabilitation Center
🇺🇸
Middletown, Connecticut, United States
Masonicare Health Center
🇺🇸
Wallingford, Connecticut, United States
Northbridge Health Care Center
🇺🇸
Bridgeport, Connecticut, United States
Laurel Ridge Health Care Center
🇺🇸
Ridgefield, Connecticut, United States
Glastonbury Health Care Center
🇺🇸
Glastonbury, Connecticut, United States
Middlesex Health Care Center
🇺🇸
Middletown, Connecticut, United States
The Carolton Chronic and Convalescent Hospital
🇺🇸
Fairfield, Connecticut, United States
Beacon Brook Health Care Center
🇺🇸
Naugatuck, Connecticut, United States
Maefair Health Care Center
🇺🇸
Trumbull, Connecticut, United States
Saint Mary Home
🇺🇸
West Hartford, Connecticut, United States
Shady Knoll Health Center
🇺🇸
Seymour, Connecticut, United States
Litchfield Woods Health Care Center
🇺🇸
Torrington, Connecticut, United States