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Clinical Trials in the EU / 2026-526444-13-01
Authorised, not yet recruiting Phase III

Preventing urinary tract infections in infants and young children with probiotic E. coli Nissle: FinNissle randomized controlled trial

2026-526444-13-01 · tracked via the Priya Life Science EU tracker
Sponsor
Pohjois-Pohjanmaan hyvinvointialue
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
10/07/2026
Enrollment target
250
Sites
Finland

Condition studied

Urinary tract infection or Pyelonephritis

Investigational medicinal product(s)

Mutaflor 10^8 CFU/ml oraalisuspensio• Alternative 1 (DF-2004 standard): Sucrose 630 mg/gPurified Water (Aqua purificata) 370 mg/g. • Alternative 2 (DAB standard): Sucrose (Saccharum) 640 mg/gPurified Water (Aqua purificata) 360 mg/g.

Eligibility

Age group
0-17 years
Sex
Female, Male

Primary endpoint

The proportion of children with a recurrent UTI during 6-month follow up.

Endpoint detail

Number of culture-confirmed UTIs per person-years at risk (PYR), Number of hospitalization days due to UTIs, Number of days of antibiotic treatment for suspected/confirmed UTIs after the initial study entry antibiotics end, Number of days of antibiotic treatment for any reason after initial antibiotics end, Number of days the child experienced abdominal pain, Number of days the child experienced diarrhoea

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-526444-13-01 on CTIS ↗ ← All trials in the EU