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Preventing urinary tract infections in infants and young children with probiotic E. coli Nissle: FinNissle randomized controlled trial
EU CTIS ID: 2026-526444-13-01
What this study is testing
The aim is to investigate the efficacy of the E. coli Nissle probiotic product in preventing recurrent UTIs in children. The study is a randomized, double-blind clinical trial. The intervention is a 30-day oral course of the E. coli Nissle probiotic. Participation is offered to infants and small children (< 2 years) treated for febrile UTIs at children's hospitals who do not have urinary tract anomalies requiring immediate surgery or antibiotic prophylaxis. The intervention begins at home immediately after antibiotic treatment ends. The primary objective is to investigate whether E.coli Nissle prevents the recurrent UTIs in infants and young children. The primary outcome variable is the proportion of children with recurrent UTI during 6-month follow up.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects meeting all the criteria below may be included in the study. To be eligible for inclusion, each subject must meet each of the following criteria at Screening and must continue to fulfil these criteria at Baseline.: -Age and History: Children under 2 years of age who are diagnosed with their first lifetime urinary tract infection (UTI) in a pediatric emergency room or ward. -UTI Definition at Entry: - -The recruiting clinical physician must consider a UTI probable based on the following: -Pyuria is confirmed from a urine sample. -The patient has symptoms compatible with a UTI (e.g., fever or local symptoms). -No other more likely diagnosis explains the symptoms. -If a preliminary or final bacterial culture result is available, it must support a UTI diagnosis. -Culture Result Exemption: A final culture result is not strictly required for inclusion if the other criteria are met and the patient is being discharged from the ward with a UTI diagnosis before the result is finalized. -Gender: Both sexes are accepted. -Probiotic Use: The use of other probiotics is allowed, but it must be recorded. -Consent: Informed consent must be obtained from all parents. -Study Sites: Recruitment takes place at the following six hospitals with pediatric wards in Finland: OYS, HUS, KYS, TAYS, TYKS, and VKS.
You likely can't join if
- Subjects are excluded from the study if any of the following criteria is met at Screening or at Baseline: -Prematurity: Children born before 35 weeks of gestation (< 35 weeks). -Severe Infection: Life-threatening infections, such as E. coli meningitis. -Urinary Tract Anomaly: Any significant obstructive defect (suspected or confirmed) that requires care from a urologist. -Immunodeficiency. -Bowel Anomaly. -Current Medication: Regular use of antibiotic prophylaxis. -Hospital-Acquired Infection: Nosocomial infections, specifically those associated with catheter use.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.