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

Completed · Not applicable · Has a placebo group

Conditions studied: Urinary Tract Infections, Infection, Urologic Diseases

In brief

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.

Key facts

Study ID

NCT01776021

Run by

Ocean Spray Cranberries, Inc.

People needed

330

Starts

2013-01-01

Expected to finish

2015-04-01

Last updated by the study team

2015-04-27

Who can join

Age: 20 and older, up to 70. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Denver, Colorado, United States
• Study site — Edgewater, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Summerfield, Florida, United States
• Ocean Spray Cranberries Research Sites — Addison, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Edina, Minnesota, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Anderson, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Pleasant Grove, Utah, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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