Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Dietary Supplement: Once Daily Cranberry Capsule
* Dietary Supplement: Twice Daily Cranberry Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>No cranberry capsules administered | |
| Active Comparator: One cranberry capsule<br>1 650mg cranberry capsule daily | Dietary Supplement: Once Daily Cranberry Capsule<br>* 650mg capsule pure cranberry powder<br>* Other names: Theralogix: Theracran cranberry supplement, 650mg capsule;|
| Active Comparator: Two cranberry capsules<br>1 650 mg cranberry capsule twice daily (bid) | Dietary Supplement: Twice Daily Cranberry Capsules<br>* One 650mg cranberry capsule administered twice per day<br>* Other names: Theralogix: Theracran cranberry supplement, 650mg capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI, elderly, prevention, cranberry, E.Coli