NCT01861353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

5.8 years

First QC Date

May 21, 2013

Last Update Submit

May 3, 2022

Conditions

Urinary Tract InfectionPyelonephritisCystitis

Outcome Measures

Primary Outcomes (1)

  • Change of the intestinal and urinary microbiome

    3 months to 12 months

Secondary Outcomes (2)

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

    12 months

  • Time to the first recurrence

    6 months

Study Arms (2)

Cranberry-lingonberry juice

EXPERIMENTAL

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

Placebo juice

PLACEBO COMPARATOR

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

Interventions

Cranberry-lingonberry juiceOTHER
Cranberry-lingonberry juice
Placebo juiceOTHER

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

Placebo juice

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Recent confirmed urinary tract infection, diagnosed in Oulu University Hospital or Oulu Health Care Center
  • Age 1-16 years

You may not qualify if:

  • Continuous antimicrobial prophylaxis
  • Age \< 12 months or \> 16 years
  • Severe congenital kidney or other urinary tract anomaly in ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, University of Oulu

Oulu, Finland

Location

Related Publications (3)

  • Jepson RG, Mihaljevic L, Craig JC. Cranberries for treating urinary tract infections. Cochrane Database Syst Rev. 2023 Dec 14;12(12):CD001322. doi: 10.1002/14651858.CD001322.pub2.

    PMID: 38096261DERIVED

  • Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

    PMID: 37947276DERIVED

  • Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

    PMID: 37068952DERIVED

MeSH Terms

Conditions

Urinary Tract InfectionsPyelonephritisCystitis

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephritis, InterstitialNephritisKidney DiseasesPyelitisUrinary Bladder Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant in pediatric infectious diseases

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

May 1, 2013

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

FI(1)