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

Bacteriuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033383
• Other study ID #: 0908005581
• Secondary ID: K23AG028691-01A2
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2009
• Last updated: July 12, 2013
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria

Intervention

Dietary Supplement:
• Placebo
36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
• Cranberry Capsule
36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).

Locations

Country	Name	City	State
United States	Northbridge Health Care Center	Bridgeport	Connecticut
United States	Sheriden Woods Health Care Center	Bristol	Connecticut
United States	The Carolton Chronic and Convalescent Hospital	Fairfield	Connecticut
United States	Glastonbury Health Care Center	Glastonbury	Connecticut
United States	Middlesex Health Care Center	Middletown	Connecticut
United States	Wadsworth Glen Health Care and Rehabilitation Center	Middletown	Connecticut
United States	Beacon Brook Health Care Center	Naugatuck	Connecticut
United States	Laurel Ridge Health Care Center	Ridgefield	Connecticut
United States	Shady Knoll Health Center	Seymour	Connecticut
United States	Litchfield Woods Health Care Center	Torrington	Connecticut
United States	Maefair Health Care Center	Trumbull	Connecticut
United States	Masonicare Health Center	Wallingford	Connecticut
United States	Abbott Terracee Health Center	Waterbury	Connecticut
United States	Saint Mary Home	West Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Center for Research Resources (NCRR), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	One month	No
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.	one month	No
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.	one month	No