Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Full Text View

Sponsors and Collaborators:	University of Oulu Ocean Spray, Inc.
Information provided by:	University of Oulu
ClinicalTrials.gov Identifier:	NCT00638170

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

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Jarmo J Salo, MD	+35883155824	jarmo.salo@oulu.fi
Contact: Tero Kontiokari, MD	+35883155333	tero.kontiokari@ppshp.fi

Locations

Finland
University of Oulu	Recruiting
Oulu, Finland, 90140
Contact: Jarmo J Salo, MD +35883155824 jarmo.salo@oulu.fi
Contact: Tero Kontiokari, MD +35883155333 tero.kontiokari@ppshp.fi

Sponsors and Collaborators

University of Oulu

Ocean Spray, Inc.

Investigators

Study Director:

Matti Uhari, Professor

University of Oulu

More Information

Responsible Party:	University of Oulu ( Jarmo Salo/MD )
Study ID Numbers:	72/2001
Study First Received:	March 10, 2008
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00638170
Health Authority:	Finland: National Agency for Medicines

Keywords provided by University of Oulu:

Urinary Tract Infections
Cranberry
Prevention

Study placed in the following topic categories:

Urologic Diseases
Urinary Tract Infections

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009