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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01033383
First received: December 15, 2009
Last updated: July 12, 2013
Last verified: July 2013
  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: Cranberry Capsule
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:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • E.Coli Bacteriuria Plus Pyuria [ Time Frame: One month ] [ Designated as safety issue: No ]
    The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.


Secondary Outcome Measures:
  • Other Bacteriuria Plus Pyuria [ Time Frame: one month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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
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 Name: 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 Name: 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 Name: Ellura

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Wadsworth Glen Health Care and Rehabilitation Center
Middletown, Connecticut, United States, 06457
Middlesex Health Care 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
Investigators
Principal Investigator: Manisha Juthani-Mehta, MD Yale School of Medicine
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01033383     History of Changes
Other Study ID Numbers: 0908005581, K23AG028691-01A2, UL1RR024139, KL2RR024138
Study First Received: December 15, 2009
Results First Received: March 19, 2013
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014