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

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Yale University

Status and phase

Completed
Phase 3

Conditions

Bacteriuria

Treatments

Dietary Supplement: Placebo
Dietary Supplement: 2 cranberry capsules

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01691430
1112009472
2P30AG021342-11 (U.S. NIH Grant/Contract)
1R01AG041153-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 reduction of bacteriuria plus pyuria in female nursing home residents. 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.

Enrollment

185 patients

Sex

Female

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. female residents;
  2. long term residents
  3. English speaking; and
  4. age ≥ 65 years.

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

185 participants in 2 patient groups, including a placebo group

2 cranberry capsules
Active Comparator group
Description:
Experimental: 2 cranberry capsules
Treatment:
Dietary Supplement: 2 cranberry capsules
2 placebo capsules
Placebo Comparator group
Description:
Experimental: 2 placebo capsules qd
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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