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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01033383
First received: December 15, 2009
Last updated: January 11, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacteriuria
 Dietary Supplement: Placebo
Dietary Supplement: 1 cranberry capsule and 2 placebo capsules
Dietary Supplement: 2 cranberry capsules and 1 placebo capsule
Dietary Supplement: 3 cranberry capsules
 Phase 1

Study Type: Interventional
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
Official Title: Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the incidence of adverse effects from cranberry capsule administration at increasing doses. [ Time Frame: One month ] [ Designated as safety issue: No ]
  • To determine the prevalence of P-fimbriated E.coli isolates among those with bacteriuria [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 3 placebo capsules Dietary Supplement: Placebo
Three placebo capsules, each 36mg, qhs
Experimental: 1 cranberry capsule & 2 placebo capsules Dietary Supplement: 1 cranberry capsule and 2 placebo capsules
1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs
Other Name: ellura
Experimental: 2 cranberry capsules & 1 placebo capsule Dietary Supplement: 2 cranberry capsules and 1 placebo capsule
2 36mg cranberry capsules, 1 placebo capsule, all qhs
Other Name: ellura
Experimental: 3 cranberry capsules Dietary Supplement: 3 cranberry capsules
3 36mg cranberry capsules qhs
Other Name: ellura

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033383

Locations
United States, Connecticut
Northbridge Health Care Center
Bridgeport, Connecticut, United States, 06606
Sheriden Woods Health Care Center
Bristol, Connecticut, United States, 06010
The Carolton Chronic and Convalescent Hospital
Fairfield, Connecticut, United States, 06824
Glastonbury Health Care Center
Glastonbury, Connecticut, United States, 06033
Middlesex Health Care Center
Middletown, Connecticut, United States, 06457
Wadsworth Glen Health Care and Rehabilitation Center
Middletown, Connecticut, United States, 06457
Beacon Brook Health Care Center
Naugatuck, Connecticut, United States, 06770
Laurel Ridge Health Care Center
Ridgefield, Connecticut, United States, 06877
Shady Knoll Health Center
Seymour, Connecticut, United States, 06483
Litchfield Woods Health Care Center
Torrington, Connecticut, United States, 06790
Maefair Health Care Center
Trumbull, Connecticut, United States, 06111
Masonicare Health Center
Wallingford, Connecticut, United States, 06492
Abbott Terracee Health Center
Waterbury, Connecticut, United States, 06702
Saint Mary Home
West Hartford, Connecticut, United States, 06117
Sponsors and Collaborators
Yale University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Manisha Juthani-Mehta, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Manisha Juthani-Mehta, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT01033383     History of Changes
Other Study ID Numbers: 0908005581, K23AG028691-01A2
Study First Received: December 15, 2009
Last Updated: January 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013