Preventing Urinary Tract Infections With E. Coli Nissle:

Secondary Prevention Clinical Trial

— FinNissle  

Official title:

Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608851
• Other study ID #: OYS_Tapiainen_002
• Status: Recruiting
• Phase: Phase 4
• Start date: January 18, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: University of Oulu
• Contact: Terhi Tapiainen
• Phone: +35883155185
• Email: terhi.tapiainen[@]oulu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Secondary Prevention
• Urinary Tract Infections
• Urinary Tract Infections in Children

Intervention

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.

Locations

Country	Name	City	State
Finland	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

Sponsors (5)

Lead Sponsor	Collaborator
University of Oulu	Helsinki University Central Hospital, Kuopio University Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of urinary tract infections	Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR)	Six months from study entry
Secondary	Hospitalization day due to bacterial culture confirmed urinary tract infection	Number of days spent in the hospital during follow up	Six months from study entry
Secondary	Antimicrobial treatment days for suspected or confirmed urinary tract infection	Number of days when study patient has received antimicrobial treatment	Six months, starting after the initial treatment at study entry has ended
Secondary	Stomach pain	Number of days with stomach pain reported by families during follow up at web-based surveys	Six months from study entry
Secondary	Diarrhea	Number of days with diarrhea reported by families during follow up at web-based survey	Six months from study entry
Secondary	Antimicrobial treatment days for any indication	Number of days when study patient has received antimicrobial treatment	Six months, starting after the initial treatment at study entry has ended