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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oulu
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Change of the intestinal and urinary microbiome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Cranberry-lingonberry juice (Other)
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.
Intervention: Placebo juice (Other)
Outcomes
Primary Outcomes
Change of the intestinal and urinary microbiome
Time Frame: 3 months to 12 months
Secondary Outcomes
- Time to the first recurrence(6 months)
- The occurrence of urinary tract infections (infection episodes/person years at risk)(12 months)
Investigators
Terhi Tapiainen
Senior consultant in pediatric infectious diseases
University of Oulu