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| ID | Type | Description | Link |
|---|---|---|---|
| DF06-005 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | No cranberry capsules administered | |
| One cranberry capsule | Active Comparator | 1 650mg cranberry capsule daily |
|
| Two cranberry capsules | Active Comparator | 1 650 mg cranberry capsule twice daily (bid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Once Daily Cranberry Capsule | Dietary Supplement | 650mg capsule pure cranberry powder |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manisha Juthani-Mehta, MD | Yale University School of Medicine, Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20929476 | Result | 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. | |
| 37947276 | Derived | Williams 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. |
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If a participant could not provide a baseline urine specimen or met an exclusion criterion prior to group assignment but after consent, he or she was not enrolled.
Four dementia units participated in this study. Exclusion criteria included: 1)indwelling catheter, 2)residence <4 weeks, 3)prednisone therapy, 4)active UTI symptoms, 5)terminal, 6)end stage renal disease, 7)<60 years old, 8)chronic suppressive antibiotic therapy, 9)history of kidney stones, 10)unable to provide baseline urine, 11)warfarin therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Cranberry Capsules | Control Group No Cranberry Capsule |
| FG001 | One Cranberry Capsule | 1 650mg cranberry capsule daily |
| FG002 | 2 Cranberry Capsules | 1 650 mg cranberry capsule twice daily (bid) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Cranberry Capsules | Control Group No Cranberry Capsule |
| BG001 | One Cranberry Capsule | 1 650mg cranberry capsule daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Cranberry Capsules | Control Group No Cranberry Capsule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders |
The inability to follow all participants for the full six months reflects the vulnerability of the population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manisha Juthani-Mehta, MD | Yale University School of Medicine | (203)785-4140 | manisha.juthanimehta@yale.edu |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Twice Daily Cranberry Capsules | Dietary Supplement | One 650mg cranberry capsule administered twice per day |
|
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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 |
| 37068952 | Derived | Williams 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. |
| Hip fracture |
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| Could not provide urine specimen |
|
| BG002 | 2 Cranberry Capsules | 1 650 mg cranberry capsule twice daily (bid) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
1 650 mg cranberry capsule twice daily (bid)
|
|
| 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. | Posted | Number | Participants | 6 months |
|
|
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| 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. | Posted | Number | Urine cultures | 6 months |
|
|
|
| 0 |
| 17 |
| 3 |
| 17 |
| EG001 | One Cranberry Capsule | 1 650mg cranberry capsule daily | 0 | 20 | 5 | 20 |
| EG002 | 2 Cranberry Capsules | 1 650 mg cranberry capsule twice daily (bid) | 0 | 19 | 3 | 19 |
| Nausea | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Gastroenteritis | Gastrointestinal disorders |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
|