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Preventing Urinary Tract Infections With E. Coli Nissle:

NCT04608851 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2022-07-06

No results posted yet for this study

Summary

Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children.

The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.

Conditions

  • Urinary Tract Infections in Children
  • Secondary Prevention

Interventions

DRUG

E. coli Nissle

1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain

OTHER

Placebo control

1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Kuopio University Hospital

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • University of Oulu

    lead OTHER

Principal Investigators

  • Terhi Tapiainen, MD, PhD · University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04608851 on ClinicalTrials.gov