Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
4 other identifiers
interventional
80
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2009
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
August 15, 2013
CompletedAugust 15, 2013
July 1, 2013
10 months
December 15, 2009
March 19, 2013
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Other Bacteriuria Plus Pyuria
one month
Not Growth
one month
Study Arms (4)
3 placebo capsules
PLACEBO COMPARATOR3 placebo capsules qd
1 cranberry capsule & 2 placebo capsules
EXPERIMENTAL1 active cranberry capsule and 2 placebo capsules qd
2 cranberry capsules & 1 placebo capsule
EXPERIMENTAL2 active cranberry capsules and 1 placebo capsules qd
3 cranberry capsules
EXPERIMENTAL3 active cranberry capsules qd
Interventions
36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).
Eligibility Criteria
You may qualify if:
- Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Aging (NIA)collaborator
- National Center for Research Resources (NCRR)collaborator
Study Sites (14)
Northbridge Health Care Center
Bridgeport, Connecticut, 06606, United States
Sheriden Woods Health Care Center
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
Related Publications (3)
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.
PMID: 22690994RESULTWilliams 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.
PMID: 37947276DERIVEDWilliams 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.
PMID: 37068952DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Of 320 urine specimens that should have been collected by nursing staff, 302 (94%) urine cultures and 294 (92%) urinalyses were obtained.
Results Point of Contact
- Title
- Dr. Manisha Juthani-Mehta
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Manisha Juthani-Mehta, MD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
December 1, 2009
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
August 15, 2013
Results First Posted
August 15, 2013
Record last verified: 2013-07