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Completed

NCT Number: NCT00596635

Cranberry for UTI Prevention in Residents of Long Term Care Facilities

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.

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Key information

Conditions

Urinary Tract Infection Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Escherichia coli Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Negative Bacterial Infections Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Once Daily Cranberry Capsule

Dietary Supplement

650mg capsule pure cranberry powder

Other names: Theralogix: Theracran cranberry supplement, 650mg capsule

Twice Daily Cranberry Capsules

Dietary Supplement

One 650mg cranberry capsule administered twice per day

Other names: Theralogix: Theracran cranberry supplement, 650mg capsule

Primary outcomes

  1. Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.

    Time frame: 6 months

    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 outcomes

  1. Number of Participants With E.Coli Isolated From Urine Culture

    Time frame: 6 months

    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.

  2. Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: PACS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 17, 2008
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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