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

Sponsor

Ocean Spray Cranberries, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01776021

Collaborator

Biofortis Clinical Research, Inc. (Industry)

330

Enrollment

Locations

Arms

26.9

Duration (Months)

19.4

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Infection Urologic Diseases	Other: cranberry juice Other: placebo beverage	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: cranberry juice cranberry juice beverage at a dose of one 8 oz. beverage per day for six months	Other: cranberry juice cranberry juice beverage at a dose of one 8 oz. beverage per day for six months
Placebo Comparator: Placebo placebo beverage at a dose of one 8 oz. beverage per day for six months	Other: placebo beverage placebo beverage at a dose of one 8 oz. beverage per day for six months

Arm

Intervention/Treatment

Active Comparator: cranberry juice

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

Other: cranberry juice

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

Placebo Comparator: Placebo

placebo beverage at a dose of one 8 oz. beverage per day for six months

Other: placebo beverage

placebo beverage at a dose of one 8 oz. beverage per day for six months

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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.
Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period prior to enrollment will be allowed.
Subject has a body mass index (BMI) >40.0 kg/m2.
Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment.
Subject has diabetes mellitus treated with insulin.
Subject has an active infection or sign/symptoms of an infection (i.e., including a UTI).
Subject has used oral anti-coagulants within the last 4 weeks.
Subject has a history or presence of cancer in the prior two years, except for nonmelanoma skin cancer.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chandler	Arizona	United States	85224
2		Scottsdale	Arizona	United States	85251
3		San Diego	California	United States	92123
4		Santa Rosa	California	United States	95405
5		Denver	Colorado	United States	80239
6		Edgewater	Florida	United States	32123
7		Miami	Florida	United States	33155
8		Summerfield	Florida	United States	34491
9	Ocean Spray Cranberries Research Sites	Addison	Illinois	United States	60101
10		Evanston	Illinois	United States	60201
11		Edina	Minnesota	United States	55435
12		Cincinnati	Ohio	United States	45249
13		Columbus	Ohio	United States	43212
14		Anderson	South Carolina	United States	29621
15		Dallas	Texas	United States	75231
16		Pleasant Grove	Utah	United States	84062
17		Salt Lake City	Utah	United States	84124