Cranberry Juice for Treatment of Urinary Tract Infections

Cranberry Juice and Urinary Tract Infections

The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Cranberry juice; Dietary supplement: Placebo cranberry juice

Detailed Description

Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Culture-confirmed urinary tract infection at study start

Exclusion Criteria:

• Other chronic disease
• Antibiotics within 48 hours prior to study start
• Hospitalization for any reason within 2 weeks prior to study start
• Stones in urinary tract
• Plans to leave Ann Arbor within 6 months after study start
• Allergy to cranberry or cranberry compounds
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Cranberry juice	Drug: Cranberry juice; TID dosage for UTI treatment
PLACEBO_COMPARATOR: 2; Placebo juice	Dietary supplement: Placebo cranberry juice; TID placebo dosage to match active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Culture	per visit

Collaborators and Investigators

• Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Cibele T. Barbosa-Cesnik, University of Michigan

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: September 30, 2004
• First Submitted That Met QC Criteria: September 30, 2004
• First Posted (ESTIMATE): October 1, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): May 5, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Vaccinium macrocarpon
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: R01AT002086 (NIH)