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Cranberry Juice in the Prevention of Urinary Tract Infections in Children

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ClinicalTrials.gov Identifier: NCT00638170
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : February 16, 2009
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by:
University of Oulu

Brief Summary:
The objective of the study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Biological: Cranberry juice Biological: Placebo juice Not Applicable

Detailed Description:
Five percent of children have at least one UTI episode and 30% of these episodes recur. Recurrences and the risk of renal damage are indications for long term antimicrobial prophylaxis, but emerging antimicrobial resistance underlines the need for alternatives. The bacteria causing urinary tract infection arise from the stools. Dietary changes can alter the balance of faecal bacteria. Vaccinium berries and products containing lactobacilli have been shown to act against the coliform bacteria that cause most urinary tract infections. In our previous study cranberry juice was effective in preventing symptomatic recurrences of urinary tract infections in women. The objective of our study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study
Study Start Date : May 2001
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Cranberry juice
Biological: Cranberry juice
5 ml/kg up to 300 ml, 1-2 doses daily for six months
Placebo Comparator: B
Placebo juice
Biological: Placebo juice
5 ml/kg up to 300 ml, 1-2 doses daily for six months



Primary Outcome Measures :
  1. Occurrence of the first recurrence [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Total number of UTI episodes and use of antimicrobials [ Time Frame: 12 months ]


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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary Tract Infection 0-2 months priorly

Exclusion Criteria:

  • Antibiotic Prophylaxis

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): NCT00638170


Locations
Finland
University of Oulu
Oulu, Finland, 90140
Sponsors and Collaborators
University of Oulu
Ocean Spray, Inc.
Investigators
Study Director: Matti Uhari, Professor University of Oulu

Responsible Party: Jarmo Salo/MD, University of Oulu
ClinicalTrials.gov Identifier: NCT00638170     History of Changes
Other Study ID Numbers: 72/2001
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: January 2008

Keywords provided by University of Oulu:
Urinary Tract Infections
Cranberry
Prevention

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