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Cranberry Juice in the Prevention of Urinary Tract Infections in Children

This study has been completed.
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00638170
First received: March 10, 2008
Last updated: February 13, 2009
Last verified: January 2008
History of Changes

March 10, 2008
February 13, 2009
May 2001
February 2009   (final data collection date for primary outcome measure)
Occurrence of the first recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00638170 on ClinicalTrials.gov Archive Site
Total number of UTI episodes and use of antimicrobials [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cranberry Juice in the Prevention of Urinary Tract Infections in Children
The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Urinary Tract Infections
  • Biological: Cranberry juice
    5 ml/kg up to 300 ml, 1-2 doses daily for six months
  • Biological: Placebo juice
    5 ml/kg up to 300 ml, 1-2 doses daily for six months
  • Active Comparator: A
    Cranberry juice
    Intervention: Biological: Cranberry juice
  • Placebo Comparator: B
    Placebo juice
    Intervention: Biological: Placebo juice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
262
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Urinary Tract Infection 0-2 months priorly

Exclusion Criteria:

  • Antibiotic Prophylaxis
Both
1 Year to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00638170
72/2001
No
Jarmo Salo/MD, University of Oulu
University of Oulu
Ocean Spray, Inc.
Study Director: Matti Uhari, Professor University of Oulu
University of Oulu
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP