Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Urinary Tract Infection Clinical Trial

— PACS  

Official title:

Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596635
• Other study ID #: 0606001581
• Secondary ID: DF06-005
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: March 19, 2013
• Start date: January 2007
• Est. completion date: August 2008

Study information

• Verified date: March 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Once Daily Cranberry Capsule
650mg capsule pure cranberry powder
• Twice Daily Cranberry Capsules
One 650mg cranberry capsule administered twice per day

Locations

Country	Name	City	State
United States	Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No