Bacteriuria
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
DIETARY_SUPPLEMENTCranberry Capsule
36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).
Sponsors
National Institute on Aging (NIA)
National Center for Research Resources (NCRR)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment of participants occurred at 11 nursing homes from December 2009 to December 2010.
Pre-assignment details
Once participants consented, they needed to be able to provide a clean catch urine specimen in order to be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 3 Placebo Capsules 3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs | 20 |
| 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 | 20 |
| 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 | 20 |
| 3 Cranberry Capsules 3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | 3 Placebo Capsules | 1 Cranberry Capsule & 2 Placebo Capsules | 2 Cranberry Capsules & 1 Placebo Capsule | 3 Cranberry Capsules |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 80 Participants | 20 Participants | 20 Participants | 20 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 89.1 years STANDARD_DEVIATION 7 | 88.8 years STANDARD_DEVIATION 8 | 88.4 years STANDARD_DEVIATION 7 | 88.8 years STANDARD_DEVIATION 5 | 90.4 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 80 participants | 20 participants | 20 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 80 Participants | 20 Participants | 20 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: One month
Population: The analysis population were those with completed labs data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Placebo Capsules | E.Coli Bacteriuria Plus Pyuria | 33 urine cultures and urinalyses |
| 1 Cranberry Capsule & 2 Placebo Capsules | E.Coli Bacteriuria Plus Pyuria | 29 urine cultures and urinalyses |
| 2 Cranberry Capsules & 1 Placebo Capsule | E.Coli Bacteriuria Plus Pyuria | 23 urine cultures and urinalyses |
| 3 Cranberry Capsules | E.Coli Bacteriuria Plus Pyuria | 25 urine cultures and urinalyses |
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.
Time frame: one month
Population: The analysis population were those with completed labs data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Placebo Capsules | Not Growth | 38 urine cultures and urinalyses |
| 1 Cranberry Capsule & 2 Placebo Capsules | Not Growth | 39 urine cultures and urinalyses |
| 2 Cranberry Capsules & 1 Placebo Capsule | Not Growth | 44 urine cultures and urinalyses |
| 3 Cranberry Capsules | Not Growth | 36 urine cultures and urinalyses |
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.
Time frame: one month
Population: The analysis population were those with completed labs data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Placebo Capsules | Other Bacteriuria Plus Pyuria | 5 urine cultures and urinalyses |
| 1 Cranberry Capsule & 2 Placebo Capsules | Other Bacteriuria Plus Pyuria | 4 urine cultures and urinalyses |
| 2 Cranberry Capsules & 1 Placebo Capsule | Other Bacteriuria Plus Pyuria | 10 urine cultures and urinalyses |
| 3 Cranberry Capsules | Other Bacteriuria Plus Pyuria | 12 urine cultures and urinalyses |