NCT04608851

Preventing Urinary Tract Infections With E. Coli Nissle:

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 530 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections in Children
• Secondary Prevention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-18
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-10-29
• Last updated: 2022-07-06

Locations

5 sites across 1 country: Finland