Preventing Urinary Tract Infections With E. Coli Nissle:

NCT04608851 | Unknown Phase 4

• 1 other identifier: OYS_Tapiainen_002
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Urinary Tract Infections; E. coli

Outcome Measures

Primary Outcomes (1)

• Recurrence of urinary tract infections

  Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection

  Six months from study entry

Secondary Outcomes (6)

• Number of urinary tract infections

  Six months from study entry

• Hospitalization day due to bacterial culture confirmed urinary tract infection

  Six months from study entry

• Antimicrobial treatment days for suspected or confirmed urinary tract infection

  Six months, starting after the initial treatment at study entry has ended

• Stomach pain

  Six months from study entry

• Diarrhea

  Six months from study entry

Study Arms (2)

Nissle group

EXPERIMENTAL

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

Drug: E. coli Nissle

Control group

PLACEBO COMPARATOR

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

Other: Placebo control

Interventions

E. coli Nissle DRUG

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

Also known as: Mutaflor

Nissle group

Placebo control OTHER

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

Control group

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who suffer of the first urinary tract infection of their life defined as pyuria, presence of symptoms (fever or focal symptom), no other explanation for infection, bacterial culture positive or culture result pending
• Written informed consent

You may not qualify if:

• Preterm birth, gestational age less than 35 weeks
• 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

Sponsors & Collaborators

• University of Oulu: lead
• Turku University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Tampere University Hospital: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (5)

Helsinki University Hospital

Helsinki, 00290, Finland

NOT YET RECRUITING

Kuopio University Hospital

Kuopio, 70210, Finland

NOT YET RECRUITING

Department of Pediatrics, Oulu University Hospital

Oulu, 90014, Finland

RECRUITING

Tampere University Hospital

Tampere, 33520, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, 20521, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Terhi Tapiainen, MD, PhD

  University of Oulu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terhi Tapiainen

CONTACT

+35883155185; terhi.tapiainen@oulu.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention drug or placebo will be given to participants in closed boxes without any labels. Appearance and dosing of the products will be similar. Investigators will not handle the boxes or study products.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Pediatrics

Model Details: Double Blinded, Placebo controlled and randomized clinical trial

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: October 29, 2020
• Study Start: January 18, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (5)