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Cranberry Juice for Treatment of Urinary Tract Infections

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ClinicalTrials.gov Identifier: NCT00093054
Recruitment Status : Completed
First Posted : October 1, 2004
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Cranberry juice Dietary Supplement: Placebo cranberry juice Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cranberry Juice and Urinary Tract Infections
Study Start Date : November 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Culture [ Time Frame: per visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093054


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Cibele T. Barbosa-Cesnik University of Michigan

Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00093054     History of Changes
Other Study ID Numbers: R01AT002086 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2004    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Vaccinium macrocarpon

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