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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG028691-01A2 | U.S. NIH Grant/Contract | View source | |
| UL1RR024139 | U.S. NIH Grant/Contract | View source | |
| KL2RR024138 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 placebo capsules | Placebo Comparator | 3 placebo capsules qd |
|
| 1 cranberry capsule & 2 placebo capsules | Experimental | 1 active cranberry capsule and 2 placebo capsules qd |
|
| 2 cranberry capsules & 1 placebo capsule | Experimental | 2 active cranberry capsules and 1 placebo capsules qd |
|
| 3 cranberry capsules | Experimental | 3 active cranberry capsules qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manisha Juthani-Mehta, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northbridge Health Care Center | Bridgeport | Connecticut | 06606 | United States | ||
| Sheriden Woods Health Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22690994 | Result | Bianco L, Perrelli E, Towle V, Van Ness PH, Juthani-Mehta M. Pilot randomized controlled dosing study of cranberry capsules for reduction of bacteriuria plus pyuria in female nursing home residents. J Am Geriatr Soc. 2012 Jun;60(6):1180-1. doi: 10.1111/j.1532-5415.2012.03976.x. No abstract available. | |
| 37947276 | Derived | Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7. |
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Once participants consented, they needed to be able to provide a clean catch urine specimen in order to be enrolled.
Recruitment of participants occurred at 11 nursing homes from December 2009 to December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Placebo Capsules | 3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs |
| FG001 | 1 Cranberry Capsule & 2 Placebo Capsules | 1 active cranberry capsule and 2 placebo capsules qd 1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cranberry Capsule | Dietary Supplement | 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs). |
|
|
| 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 |
| Bristol |
| Connecticut |
| 06010 |
| United States |
| The Carolton Chronic and Convalescent Hospital | Fairfield | Connecticut | 06824 | United States |
| Glastonbury Health Care Center | Glastonbury | Connecticut | 06033 | United States |
| Middlesex Health Care Center | Middletown | Connecticut | 06457 | United States |
| Wadsworth Glen Health Care and Rehabilitation Center | Middletown | Connecticut | 06457 | United States |
| Beacon Brook Health Care Center | Naugatuck | Connecticut | 06770 | United States |
| Laurel Ridge Health Care Center | Ridgefield | Connecticut | 06877 | United States |
| Shady Knoll Health Center | Seymour | Connecticut | 06483 | United States |
| Litchfield Woods Health Care Center | Torrington | Connecticut | 06790 | United States |
| Maefair Health Care Center | Trumbull | Connecticut | 06111 | United States |
| Masonicare Health Center | Wallingford | Connecticut | 06492 | United States |
| Abbott Terracee Health Center | Waterbury | Connecticut | 06702 | United States |
| Saint Mary Home | West Hartford | Connecticut | 06117 | United States |
| 37068952 | Derived | Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6. |
| FG002 | 2 Cranberry Capsules & 1 Placebo Capsule | 2 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs |
| FG003 | 3 Cranberry Capsules | 3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 Placebo Capsules | 3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs |
| BG001 | 1 Cranberry Capsule & 2 Placebo Capsules | 1 active cranberry capsule and 2 placebo capsules qd 1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs |
| BG002 | 2 Cranberry Capsules & 1 Placebo Capsule | 2 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs |
| BG003 | 3 Cranberry Capsules | 3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population were those with completed labs data. | Posted | Number | urine cultures and urinalyses | One month | Urine cultures and urinalyses | Participants |
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| Secondary | 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. | The analysis population were those with completed labs data. | Posted | Number | urine cultures and urinalyses | one month | Urine cultures and urinalyses | Participants |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population were those with completed labs data. | Posted | Number | urine cultures and urinalyses | one month | Urine cultures and urinalyses | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 Placebo Capsules | 3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs | 0 | 20 | 0 | 20 | ||
| EG001 | 1 Cranberry Capsule & 2 Placebo Capsules | 1 active cranberry capsule and 2 placebo capsules qd 1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs | 0 | 20 | 0 | 20 | ||
| EG002 | 2 Cranberry Capsules & 1 Placebo Capsule | 2 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs | 0 | 20 | 0 | 20 | ||
| EG003 | 3 Cranberry Capsules | 3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs | 0 | 20 | 0 | 20 |
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Of 320 urine specimens that should have been collected by nursing staff, 302 (94%) urine cultures and 294 (92%) urinalyses were obtained.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manisha Juthani-Mehta | Yale University | (203)785-7571 | manisha.juthani@yale.edu |
| ID | Term |
|---|---|
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Urine cultures and urinalyses |
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| 3 Cranberry Capsules |
3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs |
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