Clinical trial NCT01033383: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Official title: Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacteriuria
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Research Resources (NCRR)
First posted: 2009-12-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: E.Coli Bacteriuria Plus Pyuria
timeFrame: One month
Secondary outcomes:
measure: Other Bacteriuria Plus Pyuria
timeFrame: one month
measure: Not Growth
timeFrame: one month
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Northbridge Health Care Center
state: Connecticut
city: Bristol
country: United States
facility: Sheriden Woods Health Care Center
state: Connecticut
city: Fairfield
country: United States
facility: The Carolton Chronic and Convalescent Hospital
state: Connecticut
city: Glastonbury
country: United States
facility: Glastonbury Health Care Center
state: Connecticut
city: Middletown
country: United States
facility: Middlesex Health Care Center
state: Connecticut
city: Middletown
country: United States
facility: Wadsworth Glen Health Care and Rehabilitation Center
state: Connecticut
city: Naugatuck
country: United States
facility: Beacon Brook Health Care Center
state: Connecticut
city: Ridgefield
country: United States
facility: Laurel Ridge Health Care Center
state: Connecticut
city: Seymour
country: United States
facility: Shady Knoll Health Center
state: Connecticut
city: Torrington
country: United States
facility: Litchfield Woods Health Care Center
state: Connecticut
city: Trumbull
country: United States
facility: Maefair Health Care Center
state: Connecticut
city: Wallingford
country: United States
facility: Masonicare Health Center
state: Connecticut
city: Waterbury
country: United States
facility: Abbott Terracee Health Center
state: Connecticut
city: West Hartford
country: United States
facility: Saint Mary Home
state: Connecticut
Study officials:
affiliation: Yale University
name: Manisha Juthani-Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.