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

Primary Purpose

Bacteriuria

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Cranberry Capsule
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteriuria

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Northbridge Health Care Center
  • Sheriden Woods Health Care Center
  • The Carolton Chronic and Convalescent Hospital
  • Glastonbury Health Care Center
  • Middlesex Health Care Center
  • Wadsworth Glen Health Care and Rehabilitation Center
  • Beacon Brook Health Care Center
  • Laurel Ridge Health Care Center
  • Shady Knoll Health Center
  • Litchfield Woods Health Care Center
  • Maefair Health Care Center
  • Masonicare Health Center
  • Abbott Terracee Health Center
  • Saint Mary Home

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

3 placebo capsules

1 cranberry capsule & 2 placebo capsules

2 cranberry capsules & 1 placebo capsule

3 cranberry capsules

Arm Description

3 placebo capsules qd

1 active cranberry capsule and 2 placebo capsules qd

2 active cranberry capsules and 1 placebo capsules qd

3 active cranberry capsules qd

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 15, 2009
Last Updated
July 12, 2013
Sponsor
Yale University
Collaborators
National Institute on Aging (NIA), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01033383
Brief Title
Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Official Title
Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Aging (NIA), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteriuria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 placebo capsules
Arm Type
Placebo Comparator
Arm Description
3 placebo capsules qd
Arm Title
1 cranberry capsule & 2 placebo capsules
Arm Type
Experimental
Arm Description
1 active cranberry capsule and 2 placebo capsules qd
Arm Title
2 cranberry capsules & 1 placebo capsule
Arm Type
Experimental
Arm Description
2 active cranberry capsules and 1 placebo capsules qd
Arm Title
3 cranberry capsules
Arm Type
Experimental
Arm Description
3 active cranberry capsules qd
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry Capsule
Other Intervention Name(s)
Ellura
Intervention Description
36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).
Primary Outcome Measure Information:
Title
E.Coli Bacteriuria Plus Pyuria
Description
The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Other Bacteriuria Plus Pyuria
Description
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.
Time Frame
one month
Title
Not Growth
Description
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.
Time Frame
one month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Juthani-Mehta, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northbridge Health Care Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Sheriden Woods Health Care Center
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
The Carolton Chronic and Convalescent Hospital
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Glastonbury Health Care Center
City
Glastonbury
State/Province
Connecticut
ZIP/Postal Code
06033
Country
United States
Facility Name
Middlesex Health Care Center
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Wadsworth Glen Health Care and Rehabilitation Center
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Beacon Brook Health Care Center
City
Naugatuck
State/Province
Connecticut
ZIP/Postal Code
06770
Country
United States
Facility Name
Laurel Ridge Health Care Center
City
Ridgefield
State/Province
Connecticut
ZIP/Postal Code
06877
Country
United States
Facility Name
Shady Knoll Health Center
City
Seymour
State/Province
Connecticut
ZIP/Postal Code
06483
Country
United States
Facility Name
Litchfield Woods Health Care Center
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Maefair Health Care Center
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06111
Country
United States
Facility Name
Masonicare Health Center
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Facility Name
Abbott Terracee Health Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06702
Country
United States
Facility Name
Saint Mary Home
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22690994
Citation
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.
Results Reference
result

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

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