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Preventing Urinary Tract Infections With E. Coli Nissle: (FinNissle)

Primary Purpose

Urinary Tract Infections in Children, Secondary Prevention

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
E. coli Nissle
Placebo control
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections in Children focused on measuring Urinary Tract Infections, E. coli

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Helsinki University Hospital
  • Kuopio University Hospital
  • Department of Pediatrics, Oulu University HospitalRecruiting
  • Tampere University Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nissle group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of urinary tract infections
Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR)
Hospitalization day due to bacterial culture confirmed urinary tract infection
Number of days spent in the hospital during follow up
Antimicrobial treatment days for suspected or confirmed urinary tract infection
Number of days when study patient has received antimicrobial treatment
Stomach pain
Number of days with stomach pain reported by families during follow up at web-based surveys
Diarrhea
Number of days with diarrhea reported by families during follow up at web-based survey
Antimicrobial treatment days for any indication
Number of days when study patient has received antimicrobial treatment

Full Information

First Posted
October 28, 2020
Last Updated
July 5, 2022
Sponsor
University of Oulu
Collaborators
Turku University Hospital, Kuopio University Hospital, Tampere University Hospital, Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04608851
Brief Title
Preventing Urinary Tract Infections With E. Coli Nissle:
Acronym
FinNissle
Official Title
Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Turku University Hospital, Kuopio University Hospital, Tampere University Hospital, Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In order to asses efficacy of E. coli Nissle strain in prevention of recurrent UTIs in children, we aim to conduct randomized, placebo controlled and double blinded clinical trial. We are going to recruit children who are suffering the first urinary tract infection of their life. The UTI will be treated by normal clinical recommendations decided by treating physician. Intervention will start on the day following the last day of the antimicrobial course. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections in Children, Secondary Prevention
Keywords
Urinary Tract Infections, E. coli

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double Blinded, Placebo controlled and randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nissle group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
E. coli Nissle
Other Intervention Name(s)
Mutaflor
Intervention Description
1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain
Intervention Type
Other
Intervention Name(s)
Placebo control
Intervention Description
1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.
Primary Outcome Measure Information:
Title
Recurrence of urinary tract infections
Description
Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection
Time Frame
Six months from study entry
Secondary Outcome Measure Information:
Title
Number of urinary tract infections
Description
Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR)
Time Frame
Six months from study entry
Title
Hospitalization day due to bacterial culture confirmed urinary tract infection
Description
Number of days spent in the hospital during follow up
Time Frame
Six months from study entry
Title
Antimicrobial treatment days for suspected or confirmed urinary tract infection
Description
Number of days when study patient has received antimicrobial treatment
Time Frame
Six months, starting after the initial treatment at study entry has ended
Title
Stomach pain
Description
Number of days with stomach pain reported by families during follow up at web-based surveys
Time Frame
Six months from study entry
Title
Diarrhea
Description
Number of days with diarrhea reported by families during follow up at web-based survey
Time Frame
Six months from study entry
Title
Antimicrobial treatment days for any indication
Description
Number of days when study patient has received antimicrobial treatment
Time Frame
Six months, starting after the initial treatment at study entry has ended

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terhi Tapiainen
Phone
+35883155185
Email
terhi.tapiainen@oulu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harri Saxen, MD, PhD
Email
harri.saxen@hus.fi
First Name & Middle Initial & Last Name & Degree
Tea Nieminen, MD, PhD
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjo Renko, MD, Phd
Email
marjo.renko@uef.fi
First Name & Middle Initial & Last Name & Degree
Katri Backman, MD, PhD
First Name & Middle Initial & Last Name & Degree
Päivi Kallunki-Saesmaa, MD, PhD
Facility Name
Department of Pediatrics, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90014
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
Phone
+358-8-315 5185
Email
terhi.tapiainen@oulu.fi
First Name & Middle Initial & Last Name & Degree
Niko Paalanne, MD, PhD
Phone
+358-8-315-8427
Email
niko.paalanne@oulu.fi
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mikael Hakkola, BM
First Name & Middle Initial & Last Name & Degree
Niko Paalanne, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kimmo Halt, MD
First Name & Middle Initial & Last Name & Degree
Tytti Pokka, MSc
First Name & Middle Initial & Last Name & Degree
Ulla Koskela, MD, PhD
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merja Helminen, MD, PhD
Email
merja.helminen@pshp.fi
First Name & Middle Initial & Last Name & Degree
Sari Törmänen, MD
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ville Peltola, MD, PhD
Email
ville.peltola@utu.fi
First Name & Middle Initial & Last Name & Degree
Lauri Ivaska, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared after reasonable request

Learn more about this trial

Preventing Urinary Tract Infections With E. Coli Nissle:

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