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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
Terhi Tapiainen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01861353
First received: May 21, 2013
Last updated: September 11, 2013
Last verified: September 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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, the Uropathogenic Escherichia Coli Strains, and the Chemical Composition of Urine and Feces in Children

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Time to the first urinary tract infection episode [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of urinary tract infections (infection episodes/person years at risk) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Gut microbiota [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes of gut microbiota analyzed by 16S RNA sequencing

  • Chemical composition of urine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Chemical composition of feces [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Analysis of uropathogenic strains causing recurrences [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 2017
Estimated Primary Completion Date: May 2016 (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.


  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 21, 2013
Last Updated: September 11, 2013
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014