Clinical trial NCT01776021: Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Infection
Urologic Diseases
Keywords: Urinary tract infection
Recurrent urinary tract infection
Cranberry
Prevention
E-coli
Lead sponsor: Ocean Spray Cranberries, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Clinical Research, Inc.
First posted: 2013-01-25
Enrollment: 330
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: six months
Secondary outcomes:
measure: 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.
timeFrame: six months
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Edgewater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Summerfield
country: United States
state: Florida
city: Addison
country: United States
facility: Ocean Spray Cranberries Research Sites
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Edina
country: United States
state: Minnesota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Anderson
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Pleasant Grove
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Biofortis Clinical Research, Inc.
name: Kevin Maki, PhD
role: STUDY_DIRECTOR
References:
citation: Straub TJ, Chou WC, Manson AL, Schreiber HL 4th, Walker BJ, Desjardins CA, Chapman SB, Kaspar KL, Kahsai OJ, Traylor E, Dodson KW, Hullar MAJ, Hultgren SJ, Khoo C, Earl AM. Limited effects of long-term daily cranberry consumption on the gut microbiome in a placebo-controlled study of women with recurrent urinary tract infections. BMC Microbiol. 2021 Feb 18;21(1):53. doi: 10.1186/s12866-021-02106-4.
citation: Maki KC, Kaspar KL, Khoo C, Derrig LH, Schild AL, Gupta K. Consumption of a cranberry juice beverage lowered the number of clinical urinary tract infection episodes in women with a recent history of urinary tract infection. Am J Clin Nutr. 2016 Jun;103(6):1434-42. doi: 10.3945/ajcn.116.130542.