Trial Outcomes & Findings for Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents (NCT NCT01033383)
NCT ID: NCT01033383
Last Updated: 2013-08-15
Results Overview
The number of urine cultures and urinalyses (obtained weekly) found with \>100,000 CFU/ml growth of E.coli and \>10 WBC.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
One month
Results posted on
2013-08-15
Participant Flow
Recruitment of participants occurred at 11 nursing homes from December 2009 to December 2010.
Once participants consented, they needed to be able to provide a clean catch urine specimen in order to be enrolled.
Participant milestones
| Measure |
3 Placebo Capsules
3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs
|
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
|
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
|
3 Cranberry Capsules
3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Baseline characteristics by cohort
| Measure |
3 Placebo Capsules
n=20 Participants
3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs
|
1 Cranberry Capsule & 2 Placebo Capsules
n=20 Participants
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
|
2 Cranberry Capsules & 1 Placebo Capsule
n=20 Participants
2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules \& 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs
|
3 Cranberry Capsules
n=20 Participants
3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Age Continuous
|
88.8 years
STANDARD_DEVIATION 8 • n=5 Participants
|
88.4 years
STANDARD_DEVIATION 7 • n=7 Participants
|
88.8 years
STANDARD_DEVIATION 5 • n=5 Participants
|
90.4 years
STANDARD_DEVIATION 7 • n=4 Participants
|
89.1 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: The analysis population were those with completed labs data.
The number of urine cultures and urinalyses (obtained weekly) found with \>100,000 CFU/ml growth of E.coli and \>10 WBC.
Outcome measures
| Measure |
3 Placebo Capsules
n=76 Urine cultures and urinalyses
3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs
|
1 Cranberry Capsule & 2 Placebo Capsules
n=72 Urine cultures and urinalyses
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
|
2 Cranberry Capsules & 1 Placebo Capsule
n=77 Urine cultures and urinalyses
2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules \& 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs
|
3 Cranberry Capsules
n=73 Urine cultures and urinalyses
3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs
|
|---|---|---|---|---|
|
E.Coli Bacteriuria Plus Pyuria
|
33 urine cultures and urinalyses
|
29 urine cultures and urinalyses
|
23 urine cultures and urinalyses
|
25 urine cultures and urinalyses
|
SECONDARY outcome
Timeframe: one monthPopulation: The analysis population were those with completed labs data.
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.
Outcome measures
| Measure |
3 Placebo Capsules
n=76 Urine cultures and urinalyses
3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs
|
1 Cranberry Capsule & 2 Placebo Capsules
n=72 Urine cultures and urinalyses
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
|
2 Cranberry Capsules & 1 Placebo Capsule
n=77 Urine cultures and urinalyses
2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules \& 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs
|
3 Cranberry Capsules
n=73 Urine cultures and urinalyses
3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs
|
|---|---|---|---|---|
|
Other Bacteriuria Plus Pyuria
|
5 urine cultures and urinalyses
|
4 urine cultures and urinalyses
|
10 urine cultures and urinalyses
|
12 urine cultures and urinalyses
|
SECONDARY outcome
Timeframe: one monthPopulation: The analysis population were those with completed labs data.
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.
Outcome measures
| Measure |
3 Placebo Capsules
n=76 Urine cultures and urinalyses
3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs
|
1 Cranberry Capsule & 2 Placebo Capsules
n=72 Urine cultures and urinalyses
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
|
2 Cranberry Capsules & 1 Placebo Capsule
n=77 Urine cultures and urinalyses
2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules \& 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs
|
3 Cranberry Capsules
n=73 Urine cultures and urinalyses
3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs
|
|---|---|---|---|---|
|
Not Growth
|
38 urine cultures and urinalyses
|
39 urine cultures and urinalyses
|
44 urine cultures and urinalyses
|
36 urine cultures and urinalyses
|
Adverse Events
3 Placebo Capsules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 Cranberry Capsule & 2 Placebo Capsules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Cranberry Capsules & 1 Placebo Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Cranberry Capsules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place