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Cranberry for UTI Prevention in Residents of Long Term Care Facilities (PACS)

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Once Daily Cranberry Capsule
Twice Daily Cranberry Capsules
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring UTI, elderly, prevention, cranberry, E.Coli

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Greater than 60 years old and a resident of the nursing home or assisted living facility for greater than 30 days duration

Exclusion Criteria:

  • Having a known major anatomic abnormality of the urinary tract
  • Presence of acute UTI symptom
  • Intolerance or allergy to cranberry products
  • Current use of cranberry for prevention of UTI
  • Use of warfarin
  • History of kidney stones
  • Presence of a chronic indwelling bladder catheter
  • Dialysis dependence
  • Chronic suppressive antibiotics
  • Immunocompromised state due to hematological malignancies, HIV infection, chronic high dose (>10mg daily) prednisone or equivalent steroid use.

Sites / Locations

  • Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control Group

One cranberry capsule

Two cranberry capsules

Arm Description

No cranberry capsules administered

1 650mg cranberry capsule daily

1 650 mg cranberry capsule twice daily (bid)

Outcomes

Primary Outcome Measures

Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.
Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.

Secondary Outcome Measures

Number of Participants With E.Coli Isolated From Urine Culture
Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.
Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture
Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.

Full Information

First Posted
January 8, 2008
Last Updated
March 19, 2013
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00596635
Brief Title
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Acronym
PACS
Official Title
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the health care industry over 1 billion dollars annually. The incidence of UTI increases markedly in elderly institutionalized persons and leads to excessive antimicrobial usage, emergency room visits, hospitalization, sepsis, and death. The use of antimicrobials to prevent UTI in elderly nursing home patients is not recommended and is fraught with problems such as adverse reactions, drug interactions, and the development of drug-resistant organisms. There is no accepted method of preventing UTI in residents of nursing homes, a vulnerable and understudied population with significant morbidity from UTI. The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for future larger studies.
Detailed Description
Cranberry products represent a novel, non-antimicrobial method for prevention of UTI. There is evidence for a plausible mechanism and efficacy for UTI prevention in healthy premenopausal women. Limited clinical studies of cranberry products in elderly men and women have demonstrated reductions in bacteriuria but have not been of adequate size or quality to support the use of cranberry in this population or result in changes in patient care. Thus, a properly designed, definitive study demonstrating efficacy of cranberry in preventing UTI in this population is needed. However, before a large-scale, placebo-controlled trial can be justified, the complexities inherent to studying older nursing home residents need to be addressed. These include issues related to collecting uncontaminated urine samples, understanding the microbiology of UTI in this population, and devising an acceptable intervention regimen. The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims listed below is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for a future RO1 level grant application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
UTI, elderly, prevention, cranberry, E.Coli

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No cranberry capsules administered
Arm Title
One cranberry capsule
Arm Type
Active Comparator
Arm Description
1 650mg cranberry capsule daily
Arm Title
Two cranberry capsules
Arm Type
Active Comparator
Arm Description
1 650 mg cranberry capsule twice daily (bid)
Intervention Type
Dietary Supplement
Intervention Name(s)
Once Daily Cranberry Capsule
Other Intervention Name(s)
Theralogix: Theracran cranberry supplement, 650mg capsule
Intervention Description
650mg capsule pure cranberry powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Twice Daily Cranberry Capsules
Other Intervention Name(s)
Theralogix: Theracran cranberry supplement, 650mg capsule
Intervention Description
One 650mg cranberry capsule administered twice per day
Primary Outcome Measure Information:
Title
Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.
Description
Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With E.Coli Isolated From Urine Culture
Description
Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.
Time Frame
6 months
Title
Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture
Description
Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Greater than 60 years old and a resident of the nursing home or assisted living facility for greater than 30 days duration Exclusion Criteria: Having a known major anatomic abnormality of the urinary tract Presence of acute UTI symptom Intolerance or allergy to cranberry products Current use of cranberry for prevention of UTI Use of warfarin History of kidney stones Presence of a chronic indwelling bladder catheter Dialysis dependence Chronic suppressive antibiotics Immunocompromised state due to hematological malignancies, HIV infection, chronic high dose (>10mg daily) prednisone or equivalent steroid use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Juthani-Mehta, MD
Organizational Affiliation
Yale University School of Medicine, Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20929476
Citation
Juthani-Mehta M, Perley L, Chen S, Dziura J, Gupta K. Feasibility of cranberry capsule administration and clean-catch urine collection in long-term care residents. J Am Geriatr Soc. 2010 Oct;58(10):2028-30. doi: 10.1111/j.1532-5415.2010.03080.x. No abstract available.
Results Reference
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Cranberry for UTI Prevention in Residents of Long Term Care Facilities

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