A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents

• Number of episodes of UTI [ Time Frame: One year ] [ Designated as safety issue: No ]
  UTI episodes that are recorded in the medical record by the primary provider will be collected by chart review.
• Number of hospitalizations [ Time Frame: One year ] [ Designated as safety issue: Yes ]
• Number of deaths [ Time Frame: One year ] [ Designated as safety issue: Yes ]
• Number of antibiotic prescriptions [ Time Frame: One year ] [ Designated as safety issue: No ]
  Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.
• Number of multi-drug resistant organisms in each participant [ Time Frame: One year ] [ Designated as safety issue: No ]
  Chart review will be performed to determine if multi-drug resistant organisms were isolated from clinical samples (e.g., sputum, urine, blood cultures) submitted by the primary provider.

• Number of adverse events in participants [ Time Frame: One year ] [ Designated as safety issue: Yes ]
• Adherence to capsule intake by all participants [ Time Frame: One year ] [ Designated as safety issue: No ]

Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the prevention of bacteriuria in female nursing home residents. The secondary aim is to compare the occurrence of urinary tract specific symptoms in the cranberry capsule versus placebo groups. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.

• Dietary Supplement: 2 cranberry capsules
  Two 36mg cranberry capsules all qhs
  Other Name: Ellura
• Dietary Supplement: Placebo
  Two 36mg placebo capsules all qhs
  Other Name: Placebo

• Active Comparator: 2 cranberry capsules
  Experimental: 2 cranberry capsules
  Intervention: Dietary Supplement: 2 cranberry capsules
• Placebo Comparator: 2 placebo capsules
  Experimental: 2 placebo capsules all qhs
  Intervention: Dietary Supplement: Placebo

Inclusion Criteria:

1. female residents;
2. age ≥ 65 years;
3. long term residents

Exclusion Criteria:

1. 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]);
2. residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
3. residents with end stage renal disease on dialysis (they do not regularly produce urine);
4. residents unable to produce a baseline clean catch urine specimen for collection;
5. residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
6. residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
7. have an indwelling bladder catheter in place;
8. have an allergy to cranberry products;
9. are being treated with cranberry products;
10. residence <4 weeks.