Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children

May 3, 2022 updated by: Terhi Tapiainen, University of Oulu

Randomized Controlled Trial of the Effect of Cranberry-lingonberry Juice on the Occurrence of Urinary Tract Infections, the Gut Microbiota, and the Uropathogenic Escherichia Coli

Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and in adults in our earlier clinical trials. The preventive effect was, however, observed late in the follow-up and the next recurrence was not prevented in children. The investigators hypothesize that cranberry-lingonberry juice should be started already during the antimicrobial treatment of acute urinary tract infection in order to maximize the preventive efficacy of the juice. In addition, the investigators aim to find the explanation for the efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical composition of urine and feces as well as the changes of gut microbiota.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Department of Pediatrics, University of Oulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent confirmed urinary tract infection, diagnosed in Oulu University Hospital or Oulu Health Care Center
  • Age 1-16 years

Exclusion Criteria:

  • Continuous antimicrobial prophylaxis
  • Age < 12 months or > 16 years
  • Severe congenital kidney or other urinary tract anomaly in ultrasound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cranberry-lingonberry juice

Cranberry-lingonberry juice. Cranberry 12.8%, Lingonberry 12.4%, together 38g/l, contains added sugars 10g/dL.

Dose is 5 mL/kg/day, max. 300 ml/day per day. Juice was manufactured and donated by Eckes-Granini, Finland
Other: Cranberry-lingonberry juice
Placebo Comparator: Placebo juice

Contains no cranberry or lingonberry extracts. Added sugars 10g/dL (same as in the active juice group). Contains natural cranberry flavour and red anthocyanin colour. Contains 5.5 g/L citric acid. Has been tested by chemists and does not contains PAC-compounds which are thought to be the main active compound in cranberry juice.

Placebo juice was manufactured by Eckes-Granini. Dose is 5 mL/kg/day, max. 300 mL/day.
Other: Placebo juice
Juice iwth similar sugar concentration as cranberry-lingonberry juice but without berry extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the intestinal and urinary microbiome
Time Frame: 3 months to 12 months
3 months to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of urinary tract infections (infection episodes/person years at risk)
Time Frame: 12 months
12 months
Time to the first recurrence
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EETTMK74/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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