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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01033383
• Collaborator: National Institute on Aging (NIA) (NIH), National Center for Research Resources (NCRR) (NIH)
• Enrollment: 80
• Locations: 14
• Arms: 4
• Duration (Months): 12
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacteriuria	Dietary Supplement: Placebo; Dietary Supplement: Cranberry Capsule	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northbridge Health Care Center	Bridgeport	Connecticut	United States	06606
2	Sheriden Woods Health Care Center	Bristol	Connecticut	United States	06010
3	The Carolton Chronic and Convalescent Hospital	Fairfield	Connecticut	United States	06824
4	Glastonbury Health Care Center	Glastonbury	Connecticut	United States	06033
5	Middlesex Health Care Center	Middletown	Connecticut	United States	06457
6	Wadsworth Glen Health Care and Rehabilitation Center	Middletown	Connecticut	United States	06457
7	Beacon Brook Health Care Center	Naugatuck	Connecticut	United States	06770
8	Laurel Ridge Health Care Center	Ridgefield	Connecticut	United States	06877
9	Shady Knoll Health Center	Seymour	Connecticut	United States	06483
10	Litchfield Woods Health Care Center	Torrington	Connecticut	United States	06790
11	Maefair Health Care Center	Trumbull	Connecticut	United States	06111
12	Masonicare Health Center	Wallingford	Connecticut	United States	06492
13	Abbott Terracee Health Center	Waterbury	Connecticut	United States	06702
14	Saint Mary Home	West Hartford	Connecticut	United States	06117

Sponsors and Collaborators

• Yale University
• National Institute on Aging (NIA)
• National Center for Research Resources (NCRR)

Investigators

• Principal Investigator: Manisha Juthani-Mehta, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01033383
• Other Study ID Numbers: 0908005581; K23AG028691-01A2; UL1RR024139; KL2RR024138
• First Posted: Dec 16, 2009
• Last Update Posted: Aug 15, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Bacteriuria

Study Results

Participant Flow

Recruitment Details	Recruitment of participants occurred at 11 nursing homes from December 2009 to December 2010.
Pre-assignment Detail	Once participants consented, they needed to be able to provide a clean catch urine specimen in order to be enrolled.

Arm/Group Title	3 Placebo Capsules	1 Cranberry Capsule & 2 Placebo Capsules	2 Cranberry Capsules & 1 Placebo Capsule	3 Cranberry Capsules
Arm/Group Description	3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs	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 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs	3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs
Period Title: Overall Study
STARTED	20	20	20	20
COMPLETED	20	20	20	20
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	3 Placebo Capsules	1 Cranberry Capsule & 2 Placebo Capsules	2 Cranberry Capsules & 1 Placebo Capsule	3 Cranberry Capsules	Total
Arm/Group Description	3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs	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 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs	3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs	Total of all reporting groups
Overall Participants	20	20	20	20	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	20 100%	20 100%	20 100%	20 100%	80 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	88.8 (8)	88.4 (7)	88.8 (5)	90.4 (7)	89.1 (7)
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	20 100%	20 100%	80 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	20 100%	20 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	E.Coli Bacteriuria Plus Pyuria
Description	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

Outcome Measure Data

Analysis Population Description

The analysis population were those with completed labs data.

Arm/Group Title	3 Placebo Capsules	1 Cranberry Capsule & 2 Placebo Capsules	2 Cranberry Capsules & 1 Placebo Capsule	3 Cranberry Capsules
Arm/Group Description	3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs	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 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs	3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs
Measure Participants	20	20	20	20
Measure Urine cultures and urinalyses	76	72	77	73
Number [urine cultures and urinalyses]	33	29	23	25

2. Secondary Outcome

Title	Other Bacteriuria Plus Pyuria
Description	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

Outcome Measure Data

Analysis Population Description

The analysis population were those with completed labs data.

Arm/Group Title	3 Placebo Capsules	1 Cranberry Capsule & 2 Placebo Capsules	2 Cranberry Capsules & 1 Placebo Capsule	3 Cranberry Capsules
Arm/Group Description	3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs	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 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs	3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs
Measure Participants	20	20	20	20
Measure Urine cultures and urinalyses	76	72	77	73
Number [urine cultures and urinalyses]	5	4	10	12

3. Secondary Outcome

Title	Not Growth
Description	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

Outcome Measure Data

Analysis Population Description

The analysis population were those with completed labs data.

Arm/Group Title	3 Placebo Capsules	1 Cranberry Capsule & 2 Placebo Capsules	2 Cranberry Capsules & 1 Placebo Capsule	3 Cranberry Capsules
Arm/Group Description	3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs	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 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs	3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs
Measure Participants	20	20	20	20
Measure Urine cultures and urinalyses	76	72	77	73
Number [urine cultures and urinalyses]	38	39	44	36

Adverse Events

Arm/Group Title	3 Placebo Capsules		1 Cranberry Capsule & 2 Placebo Capsules		2 Cranberry Capsules & 1 Placebo Capsule		3 Cranberry Capsules
Arm/Group Description	3 placebo capsules qd Placebo : Three placebo capsules, each 36mg, qhs		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 active cranberry capsules and 1 placebo capsule qd 2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs		3 active cranberry capsules qd 3 cranberry capsules : 3 36mg cranberry capsules qhs
All Cause Mortality
	3 Placebo Capsules		1 Cranberry Capsule & 2 Placebo Capsules		2 Cranberry Capsules & 1 Placebo Capsule		3 Cranberry Capsules
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	3 Placebo Capsules		1 Cranberry Capsule & 2 Placebo Capsules		2 Cranberry Capsules & 1 Placebo Capsule		3 Cranberry Capsules
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	3 Placebo Capsules		1 Cranberry Capsule & 2 Placebo Capsules		2 Cranberry Capsules & 1 Placebo Capsule		3 Cranberry Capsules
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)

Limitations/Caveats

Of 320 urine specimens that should have been collected by nursing staff, 302 (94%) urine cultures and 294 (92%) urinalyses were obtained.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.