Cranberry Juice for Treatment of Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00093054
First received: September 30, 2004
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
Drug: Cranberry juice
Dietary Supplement: Placebo cranberry juice
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cranberry Juice and Urinary Tract Infections

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Culture [ Time Frame: per visit ] [ Designated as safety issue: No ]

Enrollment: 319
Study Start Date: November 2004
Study Completion Date: December 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093054

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Investigators
Principal Investigator: Cibele T. Barbosa-Cesnik University of Michigan
  More Information

No publications provided

Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00093054     History of Changes
Other Study ID Numbers: R01 AT002086
Study First Received: September 30, 2004
Last Updated: March 11, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Vaccinium macrocarpon

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014