Text Size

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
  Purpose

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


Condition Intervention
Urinary Tract Infections
 Biological: Cranberry juice
Biological: Placebo juice

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: Prevention
Official Title: The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Occurrence of the first recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of UTI episodes and use of antimicrobials [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 262
Study Start Date: May 2001
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary Tract Infection 0-2 months priorly

Exclusion Criteria:

  • Antibiotic Prophylaxis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jarmo Salo/MD, University of Oulu
ClinicalTrials.gov Identifier: NCT00638170     History of Changes
Other Study ID Numbers: 72/2001
Study First Received: March 10, 2008
Last Updated: February 13, 2009
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013