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

This study is currently recruiting participants.
Verified May 2016 by Terhi Tapiainen, University of Oulu
Sponsor:
ClinicalTrials.gov Identifier:
NCT01861353
First Posted: May 23, 2013
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Terhi Tapiainen, University of Oulu
  Purpose
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 Intervention
Urinary Tract Infection Pyelonephritis Cystitis Other: Cranberry-lingonberry juice Other: Placebo juice

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Terhi Tapiainen, University of Oulu:

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

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

  • Chemical composition of urine [ Time Frame: 6 months ]
  • Chemical composition of feces [ Time Frame: 6 months ]

Other Outcome Measures:
  • 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)


Estimated Enrollment: 260
Study Start Date: May 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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


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

Locations
Finland
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 Submitted: May 21, 2013
First Posted: May 23, 2013
Last Update Posted: May 11, 2016
Last Verified: May 2016

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