Phase 1 N=80 Randomized Quadruple-blind Prevention

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

Bacteriuria

Bottom Line

View on ClinicalTrials.gov: NCT01033383 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: E.Coli Bacteriuria Plus Pyuria — 33; 29; 23; 25 urine cultures and urinalyses

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Placebo (Dietary_supplement); Cranberry Capsule (Dietary_supplement)
Age: Older Adult · 65+ yrs
Sex: Female
Sponsor: Yale University
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY E.Coli Bacteriuria Plus Pyuria	33; 29; 23; 25	—
SECONDARY Other Bacteriuria Plus Pyuria	5; 4; 10; 12	—
SECONDARY Not Growth	38; 39; 44; 36	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01033383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.