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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00596635
First received: January 8, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Urinary Tract Infection
 Dietary Supplement: Once Daily Cranberry Capsule
Dietary Supplement: Twice Daily Cranberry Capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 56
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
No cranberry capsules administered
Active Comparator: One cranberry capsule
1 650mg cranberry capsule daily
 Dietary Supplement: Once Daily Cranberry Capsule
650mg capsule pure cranberry powder
Other Name: Theralogix: Theracran cranberry supplement, 650mg capsule
Active Comparator: Two cranberry capsules
1 650 mg cranberry capsule twice daily (bid)
 Dietary Supplement: Twice Daily Cranberry Capsules
One 650mg cranberry capsule administered twice per day
Other Name: Theralogix: Theracran cranberry supplement, 650mg capsule

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596635

Locations
United States, Connecticut
Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Manisha Juthani-Mehta, MD Yale University School of Medicine, Assistant Professor
  More Information

Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00596635     History of Changes
Other Study ID Numbers: 0606001581, DF06-005
Study First Received: January 8, 2008
Results First Received: June 30, 2010
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
UTI
elderly
prevention
cranberry
E.Coli

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013