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

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.

Study Overview

• Status: Completed
• Conditions: Bacteriuria
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Cranberry Capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Northbridge Health Care Center
    • Bristol, Connecticut, United States, 06010
      • Sheriden Woods Health Care Center
    • Fairfield, Connecticut, United States, 06824
      • The Carolton Chronic and Convalescent Hospital
    • Glastonbury, Connecticut, United States, 06033
      • Glastonbury Health Care Center
    • Middletown, Connecticut, United States, 06457
      • Middlesex Health Care Center
    • Middletown, Connecticut, United States, 06457
      • Wadsworth Glen Health Care and Rehabilitation Center
    • Naugatuck, Connecticut, United States, 06770
      • Beacon Brook Health Care Center
    • Ridgefield, Connecticut, United States, 06877
      • Laurel Ridge Health Care Center
    • Seymour, Connecticut, United States, 06483
      • Shady Knoll Health Center
    • Torrington, Connecticut, United States, 06790
      • Litchfield Woods Health Care Center
    • Trumbull, Connecticut, United States, 06111
      • Maefair Health Care Center
    • Wallingford, Connecticut, United States, 06492
      • Masonicare Health Center
    • Waterbury, Connecticut, United States, 06702
      • Abbott Terracee Health Center
    • West Hartford, Connecticut, United States, 06117
      • Saint Mary Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3 placebo capsules; 3 placebo capsules qd	Dietary supplement: Placebo; 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
Experimental: 1 cranberry capsule & 2 placebo capsules; 1 active cranberry capsule and 2 placebo capsules qd	Dietary supplement: Placebo; 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).; Dietary supplement: Cranberry Capsule; 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).; Other Names: Ellura
Experimental: 2 cranberry capsules & 1 placebo capsule; 2 active cranberry capsules and 1 placebo capsules qd	Dietary supplement: Placebo; 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).; Dietary supplement: Cranberry Capsule; 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).; Other Names: Ellura
Experimental: 3 cranberry capsules; 3 active cranberry capsules qd	Dietary supplement: Cranberry Capsule; 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).; Other Names: Ellura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Aging (NIA); National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Manisha Juthani-Mehta, MD, Yale School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): August 15, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: 0908005581; UL1RR024139 (U.S. NIH Grant/Contract); K23AG028691-01A2 (U.S. NIH Grant/Contract); KL2RR024138 (U.S. NIH Grant/Contract)