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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
530
1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain
1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.
Helsinki University Hospital
Helsinki, Finland
NOT_YET_RECRUITINGKuopio University Hospital
Kuopio, Finland
NOT_YET_RECRUITINGDepartment of Pediatrics, Oulu University Hospital
Oulu, Finland
RECRUITINGTampere University Hospital
Tampere, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Finland
NOT_YET_RECRUITINGRecurrence of urinary tract infections
Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection
Time frame: Six months from study entry
Number of urinary tract infections
Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR)
Time frame: Six months from study entry
Hospitalization day due to bacterial culture confirmed urinary tract infection
Number of days spent in the hospital during follow up
Time frame: Six months from study entry
Antimicrobial treatment days for suspected or confirmed urinary tract infection
Number of days when study patient has received antimicrobial treatment
Time frame: Six months, starting after the initial treatment at study entry has ended
Stomach pain
Number of days with stomach pain reported by families during follow up at web-based surveys
Time frame: Six months from study entry
Diarrhea
Number of days with diarrhea reported by families during follow up at web-based survey
Time frame: Six months from study entry
Antimicrobial treatment days for any indication
Number of days when study patient has received antimicrobial treatment
Time frame: Six months, starting after the initial treatment at study entry has ended
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