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

NCT ID: NCT01861353

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-02-28

Brief Summary

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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

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Conditions

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Urinary Tract Infection Pyelonephritis Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Cranberry-lingonberry juice

Intervention Type 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.

Group Type PLACEBO_COMPARATOR

Placebo juice

Intervention Type OTHER

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

Interventions

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Cranberry-lingonberry juice

Intervention Type OTHER

Placebo juice

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Terhi Tapiainen

Senior consultant in pediatric infectious diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics, University of Oulu

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 38096261 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37947276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37068952 (View on PubMed)

Other Identifiers

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EETTMK74/2012

Identifier Type: -

Identifier Source: org_study_id

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