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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urinary Tract Infection, Pyelonephritis, Cystitis

Intervention / Treatment
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* Other: Cranberry-lingonberry juice
* Other: Placebo juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranberry-lingonberry juice<br>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<br> <br> |
| Placebo Comparator: Placebo juice<br>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<br>* Juice iwth similar sugar concentration as cranberry-lingonberry juice but without berry extracts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the intestinal and urinary microbiome |  | 3 months to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of urinary tract infections (infection episodes/person years at risk) |  | 12 months | 
| Time to the first recurrence |  | 6 months |