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CompletedNCT01861353Updated May 9, 2022

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

An interventional study of Cranberry-lingonberry juice and Placebo juice in Urinary Tract Infection, Pyelonephritis and Cystitis, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by University of Oulu · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Urinary Tract Infection
  • Pyelonephritis
  • Cystitis
03

In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's enrollment of 113 is below the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Continuous antimicrobial prophylaxis
  • Age \< 12 months or > 16 years
  • Severe congenital kidney or other urinary tract anomaly in ultrasound
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
113 participants (actual)

Study arms

  • 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

Interventions

  • OtherCranberry-lingonberry juice
  • OtherPlacebo juice

    Juice iwth similar sugar concentration as cranberry-lingonberry juice but without berry extracts

06

What researchers measure

Primary outcomes

  1. Change of the intestinal and urinary microbiome

    Time frame: 3 months to 12 months

Secondary outcomes

  1. The occurrence of urinary tract infections (infection episodes/person years at risk)

    Time frame: 12 months

  2. Time to the first recurrence

    Time frame: 6 months

07

Study locations

1 site
  • Department of Pediatrics, University of Oulu
    Oulu, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01861353
Lead sponsor
University of Oulu
Responsible party
Terhi Tapiainen (Senior consultant in pediatric infectious diseases, University of Oulu) — Principal investigator
First posted
May 23, 2013
Start date
May 2013
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
May 9, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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