Preventing Urinary Tract Infections With E. Coli Nissle:
NCT ID: NCT04608851
Last Updated: 2022-07-06
Study Results
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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UNKNOWN
PHASE4
530 participants
INTERVENTIONAL
2021-01-18
2024-12-31
Brief Summary
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The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.
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Detailed Description
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The intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Nissle group
Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral suspension containing 10 E8 CFU/ml of E coli Nissle. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days
E. coli Nissle
1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain
Control group
Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days
Placebo control
1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.
Interventions
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E. coli Nissle
1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain
Placebo control
1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Signs of life-threatening infection (such as meningitis)
* Detected anomaly in urinary tract
* Primary immunodeficiency
* Detected anomaly of GE tract
* Ongoing antimicrobial prophylaxis
* Hospital-acquired infection
2 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Kuopio University Hospital
OTHER
Tampere University Hospital
OTHER
Helsinki University Central Hospital
OTHER
University of Oulu
OTHER
Responsible Party
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Terhi Tapiainen
Adjunct Professor of Pediatrics
Principal Investigators
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Terhi Tapiainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oulu
Locations
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Helsinki University Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Department of Pediatrics, Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OYS_Tapiainen_002
Identifier Type: -
Identifier Source: org_study_id
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