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NCT01861353 Clinical Trial

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

Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01861353
Other study ID # EETTMK74/2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2013
Est. completion date February 28, 2019

Study information
Verified date May 2022
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Year to 16 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Cranberry-lingonberry juice

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

Locations
Country Name City State
Finland Department of Pediatrics, University of Oulu Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of the intestinal and urinary microbiome 3 months to 12 months
Secondary The occurrence of urinary tract infections (infection episodes/person years at risk) 12 months
Secondary Time to the first recurrence 6 months
See also
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