Preventing urinary tract infections in infants and young children with probiotic E. coli Nissle: FinNiss- trial

Phase 1

• Conditions: rinary tract infection; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2020-001769-35-FI
• Lead Sponsor: Oulu University Hopsital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-20
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Children aged less than two years treated due to urinary tract infection
Are the trial subjects under 18? yes
Number of subjects for this age range: 530
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age more than 2 years
Gestational age less than 35 weeks
Live threatening infection
Congenital intestinal or urinary tract anomaly requiring surgical treatment
Ongoing antimicrobial prophylaxis
Hospital originated infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To analyze efficacy of probiotic E. coli Nissle in preventing urinary tract infections in children;Secondary Objective: NA;Primary end point(s): Propotion of children with new urinary tract infection during follow up;Timepoint(s) of evaluation of this end point: Follow up of six months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of urinary tract infections per person years at risk<br>Hospitalization days <br>Total daily doses on antimicrobials<br>Proportion of children with stomach ache<br>Proportion of children with diarrhea;Timepoint(s) of evaluation of this end point: Follow up of six month, evaluation monthly with questionnaire