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Cranberry Juice in the Prevention of Urinary Tract Infections in Children

Primary Purpose

Urinary Tract Infections

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Cranberry juice

Placebo juice

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring Urinary Tract Infections, Cranberry, Prevention

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Urinary Tract Infection 0-2 months priorly

Exclusion Criteria:

Antibiotic Prophylaxis

Sites / Locations

University of Oulu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Cranberry juice

Placebo juice

Outcomes

Primary Outcome Measures

Occurrence of the first recurrence

Secondary Outcome Measures

Total number of UTI episodes and use of antimicrobials

Full Information

NCT ID

NCT00638170

First Posted

March 10, 2008

Last Updated

February 13, 2009

Sponsor

University of Oulu

Collaborators

Ocean Spray, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00638170

Brief Title

Cranberry Juice in the Prevention of Urinary Tract Infections in Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

May 2001 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oulu

Collaborators

Ocean Spray, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

Keywords

Urinary Tract Infections, Cranberry, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Cranberry juice

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo juice

Intervention Type

Biological

Intervention Name(s)

Cranberry juice

Intervention Description

5 ml/kg up to 300 ml, 1-2 doses daily for six months

Intervention Type

Biological

Intervention Name(s)

Placebo juice

Intervention Description

5 ml/kg up to 300 ml, 1-2 doses daily for six months

Primary Outcome Measure Information:

Title

Occurrence of the first recurrence

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Total number of UTI episodes and use of antimicrobials

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Urinary Tract Infection 0-2 months priorly Exclusion Criteria: Antibiotic Prophylaxis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matti Uhari, Professor

Organizational Affiliation

University of Oulu

Official's Role

Study Director

Facility Information:

Facility Name

University of Oulu

City

Oulu

ZIP/Postal Code

90140

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

Cranberry Juice in the Prevention of Urinary Tract Infections in Children

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