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Completed

NCT Number: NCT01033383

Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. The Yale research team will be enrolling 80 subjects in total over several nursing home locations within Connecticut.

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Key information

Conditions

Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Northbridge Health Care Center, Bridgeport, Connecticut, United States

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About this study

Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.

Exclusion criteria

  • residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
  • residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
  • residents with end stage renal disease on dialysis (they do not regularly produce urine);
  • residents unable to produce a baseline clean catch urine specimen for collection;
  • residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
  • residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.

Treatment and study plan

Placebo

Dietary Supplement

36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).

Cranberry Capsule

Dietary Supplement

36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).

Other names: Ellura

Primary outcomes

  1. E.Coli Bacteriuria Plus Pyuria

    Time frame: One month

    The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.

Secondary outcomes

  1. Other Bacteriuria Plus Pyuria

    Time frame: one month

    The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) >100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.

  2. Not Growth

    Time frame: one month

    The number of not growth, these include no growth, growth <100,000 CFU/ml, growth >100,000 CFU/ml but no WBCs, and mixed flora.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute on Aging (NIA)

Registry information

Official study title

Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2009
Registry last updated
Aug 15, 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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