Cranberry Juice in the Prevention of Urinary Tract Infections in Children

NCT ID: NCT00638170

Last Updated: 2009-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Cranberry juice

Group Type ACTIVE_COMPARATOR

Cranberry juice

Intervention Type BIOLOGICAL

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

B

Placebo juice

Group Type PLACEBO_COMPARATOR

Placebo juice

Intervention Type BIOLOGICAL

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

Interventions

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Cranberry juice

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

Intervention Type BIOLOGICAL

Placebo juice

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Urinary Tract Infection 0-2 months priorly

Exclusion Criteria

* Antibiotic Prophylaxis
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocean Spray, Inc.

INDUSTRY

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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University of Oulu

Principal Investigators

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Matti Uhari, Professor

Role: STUDY_DIRECTOR

University of Oulu

Locations

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University of Oulu

Oulu, , Finland

Site Status

Countries

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Finland

References

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Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

Reference Type DERIVED
PMID: 37947276 (View on PubMed)

Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

Reference Type DERIVED
PMID: 37068952 (View on PubMed)

Other Identifiers

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72/2001

Identifier Type: -

Identifier Source: org_study_id

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