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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526444-13-01
Enrollment
250
Registered
2026-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract infection or Pyelonephritis

Brief summary

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

Detailed description

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

Interventions

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

Sponsors

Pohjois-Pohjanmaan hyvinvointialue
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 11, 2026