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

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