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Completed

NCT Number: NCT01861353

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

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.

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Key information

Conditions

Urinary Tract Infection Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Pyelonephritis Urinary Bladder Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, University of Oulu

Oulu, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry-lingonberry juice

Other

Placebo juice

Other

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

Primary outcomes

  1. Change of the intestinal and urinary microbiome

    Time frame: 3 months to 12 months

Secondary outcomes

  1. The occurrence of urinary tract infections (infection episodes/person years at risk)

    Time frame: 12 months

  2. Time to the first recurrence

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
May 23, 2013
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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