Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

Infection Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776021
• Other study ID #: PRV-1201
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: April 24, 2015
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2013
• Source: Ocean Spray Cranberries, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of a cranberry juice beverage on rates of Urinary tract infection (UTI) recurrence in women with a history of UTI.

Description:

Urinary tract infections (UTI) are the second most common infection of any organ system and the most common urological disease in the United States, with a total annual cost of more than $3.5 billion. Although UTIs can occur in both men and women, they are about 50 times more common in adult women than adult men. It is estimated that 25% of women diagnosed with a primary UTI will suffer a recurrence within two to three months. While no universal definition has been accepted, recurrent UTI is usually defined as three episodes in the last 12 months or two episodes in the last six months following initial infection. In an estimated 75 to 95% of cases of uncomplicated UTI, Escherichia coli (E. coli) is the underlying cause.

Cranberries have historically been associated with urinary tract health, but only recently has the biologic plausibility of cranberry use in the prevention of UTI been addressed. Current research suggests that A-type proanthocyanidins, a specific class of polyphenolic compounds found uniquely abundant in cranberries, inhibit adhesion of bacteria (including multidrug resistant E.coli) to cultured epithelial cells of the urinary tract.

This study will compare the effects of a cranberry juice beverage vs placebo on rates of UTI recurrence in women with a history of UTI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subject has had at least 2 episodes of a UTI treated by a healthcare professional in the last year and at least 1 treated UTI within the last 6 months.

2. Subject is willing to avoid listed Vaccinium products (including cranberry juice, cranberries, craisins, blueberries, cranberry/blueberry powders, pills, or supplements, probiotics) for 2 weeks prior to enrollment and throughout intervention.

3. Subject agrees to avoid probiotic dietary supplements for 2 weeks prior to enrollment and throughout intervention.

4. Subject agrees to limit all probiotic-containing foods/yogurt and yogurt-containing products to no more than an 8 oz serving/d within 2 weeks prior to enrollment and throughout intervention.

5. Subject is willing to limit all soda, pop or energy drinks (diet or regular sweetened) to < 20 oz/d within 2 weeks prior to and throughout intervention.

Exclusion Criteria:

1. Subject has an in-dwelling catheter, polycystic disease, interstitial cystitis, previous urological surgery, stones, or anatomical abnormalities of the urinary tract, spinal cord injury, immuno-compromised conditions, severe renal impairment, or multiple sclerosis.

2. Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period prior to enrollment will be allowed.

3. Subject has a body mass index (BMI) >40.0 kg/m2.

4. Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment.

5. Subject has diabetes mellitus treated with insulin.

6. Subject has an active infection or sign/symptoms of an infection (i.e., including a UTI).

7. Subject has used oral anti-coagulants within the last 4 weeks.

8. Subject has a history or presence of cancer in the prior two years, except for nonmelanoma skin cancer.

9. Subject is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections
• Urologic Diseases

Intervention

Other:
• cranberry juice
cranberry juice beverage at a dose of one 8 oz. beverage per day for six months
• placebo beverage
placebo beverage at a dose of one 8 oz. beverage per day for six months

Locations

Country	Name	City	State
United States	Ocean Spray Cranberries Research Sites	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ocean Spray Cranberries, Inc.	Biofortis Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable will be UTI incidence density, defined as the semi-annualized number of UTIs in each group, adjusted for susceptible time under observation.		six months	No
Secondary	Time from randomization to first clinical UTI. Time from randomization to first clinical UTI w/ pyuria. Time from randomization to first clinical UTI w/ microbiological verification. The fraction of subjects w/ one or more episode(s) of clinical UTI.		six months	No