Back to resultsCranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children
Primary Purpose
Urinary Tract Infection, Pyelonephritis, Cystitis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cranberry-lingonberry juice
Placebo juice
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection
Eligibility 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
Sites / Locations
- Department of Pediatrics, University of Oulu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cranberry-lingonberry juice
Placebo juice
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Change of the intestinal and urinary microbiome
Secondary Outcome Measures
The occurrence of urinary tract infections (infection episodes/person years at risk)
Time to the first recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01861353
Brief Title
Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children
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 Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Pyelonephritis, Cystitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cranberry-lingonberry juice
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo juice
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cranberry-lingonberry juice
Intervention Type
Other
Intervention Name(s)
Placebo juice
Intervention Description
Juice iwth similar sugar concentration as cranberry-lingonberry juice but without berry extracts
Primary Outcome Measure Information:
Title
Change of the intestinal and urinary microbiome
Time Frame
3 months to 12 months
Secondary Outcome Measure Information:
Title
The occurrence of urinary tract infections (infection episodes/person years at risk)
Time Frame
12 months
Title
Time to the first recurrence
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Pediatrics, University of Oulu
City
Oulu
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children
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