Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections
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
1 other identifier
interventional
330
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 27, 2015
November 1, 2013
1.9 years
January 23, 2013
April 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
cranberry juice
ACTIVE COMPARATORcranberry juice beverage at a dose of one 8 oz. beverage per day for six months
Placebo
PLACEBO COMPARATORplacebo beverage at a dose of one 8 oz. beverage per day for six months
Interventions
cranberry juice beverage at a dose of one 8 oz. beverage per day for six months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ocean Spray Cranberries, Inc.lead
- Biofortis Clinical Research, Inc.collaborator
Study Sites (17)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Santa Rosa, California, 95405, United States
Unknown Facility
Denver, Colorado, 80239, United States
Unknown Facility
Edgewater, Florida, 32123, United States
Unknown Facility
Miami, Florida, 33155, United States
Unknown Facility
Summerfield, Florida, 34491, United States
Ocean Spray Cranberries Research Sites
Addison, Illinois, 60101, United States
Unknown Facility
Evanston, Illinois, 60201, United States
Unknown Facility
Edina, Minnesota, 55435, United States
Unknown Facility
Cincinnati, Ohio, 45249, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Pleasant Grove, Utah, 84062, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Related Publications (4)
Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
PMID: 37947276DERIVEDWilliams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
PMID: 37068952DERIVEDStraub 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.
PMID: 33596852DERIVEDMaki 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.
PMID: 27251185DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin Maki, PhD
Biofortis Clinical Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2013
First Posted
January 25, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
April 1, 2015
Last Updated
April 27, 2015
Record last verified: 2013-11