Clinical Trial: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
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 Summary: 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.
Sponsor: Yale University
Current Primary Outcome: E.Coli Bacteriuria Plus Pyuria [ Time Frame: One month ]
Original Primary Outcome: To determine the optimal dose of cranberry capsules that will reduce the incidence of bacteriuria among nursing home residents with a history of bacteriuria compared to controls. [ Time Frame: One month ]
Current Secondary Outcome:
- Other Bacteriuria Plus Pyuria [ Time Frame: 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.
- Not Growth [ Time Frame: 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.
Original Secondary Outcome:
- To determine the incidence of adverse effects from cranberry capsule administration at increasing doses. [ Time Frame: one month ]
- To determine the prevalence of P-fimbriated E.coli isolates among those with bacteriuria [ Time Frame: one month ]
Information By: Yale University
Dates:
Date Received: December 15, 2009
Date Started: December 2009
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013