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

Not Applicable

Completed

• Conditions: Urinary Tract Infection; Cystitis; Pyelonephritis
• Interventions: Other: Cranberry-lingonberry juice; Other: Placebo juice

• Registration Number: NCT01861353
• Lead Sponsor: University of Oulu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cranberry-lingonberry juice	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
Placebo juice	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.

Primary Outcome Measures

Name	Time	Method
Change of the intestinal and urinary microbiome	3 months to 12 months

Secondary Outcome Measures

Name	Time	Method
Time to the first recurrence	6 months
The occurrence of urinary tract infections (infection episodes/person years at risk)	12 months

Trial Locations

Locations (1)

Department of Pediatrics, University of Oulu; 🇫🇮 Oulu, Finland