Viewing Study NCT01776021



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Last Modification Date: 2024-10-26 @ 11:02 AM
Study NCT ID: NCT01776021
Status: COMPLETED
Last Update Posted: 2015-04-27
First Post: 2013-01-23

Brief Title: Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections
Sponsor: Ocean Spray Cranberries Inc
Organization: Ocean Spray Cranberries Inc

Study Overview

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
Status: COMPLETED
Status Verified Date: 2013-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 35 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 Ecoli 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None