Cranberry for UTI Prevention in Residents of Long Term Care Facilities
PACS
2 other identifiers
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
September 23, 2010
CompletedMarch 29, 2013
March 1, 2013
1.6 years
January 8, 2008
June 30, 2010
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (2)
Number of Participants With E.Coli Isolated From Urine Culture
6 months
Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture
6 months
Study Arms (3)
Control Group
NO INTERVENTIONNo cranberry capsules administered
One cranberry capsule
ACTIVE COMPARATOR1 650mg cranberry capsule daily
Two cranberry capsules
ACTIVE COMPARATOR1 650 mg cranberry capsule twice daily (bid)
Interventions
650mg capsule pure cranberry powder
One 650mg cranberry capsule administered twice per day
Eligibility Criteria
You may qualify if:
- Greater than 60 years old and a resident of the nursing home or assisted living facility for greater than 30 days duration
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases
New Haven, Connecticut, 06511, United States
Related Publications (3)
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.
PMID: 20929476RESULTWilliams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
PMID: 37947276DERIVEDWilliams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
PMID: 37068952DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The inability to follow all participants for the full six months reflects the vulnerability of the population.
Results Point of Contact
- Title
- Manisha Juthani-Mehta, MD
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Manisha Juthani-Mehta, MD
Yale University School of Medicine, Assistant Professor
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
January 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 29, 2013
Results First Posted
September 23, 2010
Record last verified: 2013-03