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

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ClinicalTrials.gov Identifier: NCT01861353
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : May 11, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Urinary Tract Infection Pyelonephritis Cystitis Other: Cranberry-lingonberry juice Other: Placebo juice

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : May 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Time to the first urinary tract infection episode [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The occurrence of urinary tract infections (infection episodes/person years at risk) [ Time Frame: 12 months ]
  2. Gut microbiota [ Time Frame: 12 months ]
    Changes of gut microbiota analyzed by 16S RNA sequencing

  3. Chemical composition of urine [ Time Frame: 6 months ]
  4. Chemical composition of feces [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Analysis of uropathogenic strains causing recurrences [ Time Frame: 12 months ]
    Analysis of UPEC strains in btoh groups in order to analyze whether the recurrence was caused by the same strain as the initial episode (relapse) or by a novel strains (reinfection)

Eligibility Criteria

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861353

Contact: Terhi Tapiainen, M.D., Ph.D. +358407054677 terhi.tapiainen@oulu.fi
Contact: Jarmo Salo, M.D., Ph.D. jarmo.salo@oulu.fi

Department of Pediatrics, University of Oulu Recruiting
Oulu, Finland
Contact: Terhi Tapiainen       terhi.tapiainen@oulu.fi   
Contact: Jarmo Salo       jarmo.salo@oulu.fi   
Principal Investigator: Terhi Tapiainen         
Sub-Investigator: Anna-Maija Hanni         
Sub-Investigator: Jarmo Salo         
Sub-Investigator: Marjo Renko         
Principal Investigator: Matti Uhari         
Sponsors and Collaborators
University of Oulu
More Information

Responsible Party: Terhi Tapiainen, Senior consultant in pediatric infectious diseases, University of Oulu
ClinicalTrials.gov Identifier: NCT01861353     History of Changes
Other Study ID Numbers: EETTMK74/2012
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Urinary Bladder Diseases
Nephritis, Interstitial
Kidney Diseases