Original Paper

European Journal of Pediatrics

, Volume 166, Issue 4, pp 311-318

Open Access This content is freely available online to anyone, anywhere at any time.

The probiotic Escherichia coli strain Nissle 1917 (EcN) stops acute diarrhoea in infants and toddlers

  • Jobst HenkerAffiliated withDepartment of Paediatrics, University Hospital Carl-Gustav-Carus Email author 
  • , Martin LaassAffiliated withDepartment of Paediatrics, University Hospital Carl-Gustav-Carus
  • , Boris M. BlokhinAffiliated withOutpatient Paediatrics, Russian State Medical University
  • , Yuriy K. BolbotAffiliated withPaediatrics No. 2, Dnepropetrovsk State Medical Academy
  • , Vitaliy G. MaydannikAffiliated withPaediatrics No. 4, City Paediatric Clinical Hospital No. 6, National Medical University
  • , Martina ElzeAffiliated withClinResearch, Institute for Monitoring, Data Management, Biometrics and Medical Writing
  • , Corinna WolffAffiliated withArdeypharm
  • , Jürgen SchulzeAffiliated withArdeypharm


In most cases, acute diarrhoea will become self-limiting during the first few days after onset. For young children, however, health risks may develop when the disease lasts longer than 3 days. The purpose of the present trial was to determine whether the stool frequency of infants and toddlers suffering from acute diarrhoea could be normalised more quickly by administering the probiotic Escherichia coli Nissle 1917 (EcN) solution than by administering a placebo. The safety of EcN were also assessed. A total of 113 children (aged 2–47 months) with acute diarrhoea (> three watery or loose stools in 24 h) were randomised to either a group receiving the probiotic EcN suspension (n = 55) or a group receiving the placebo suspension (n = 58) in a confirmative, double-blind clinical trial. Depending on the age of patients, 1–3 ml per day of verum suspension (108 viable EcN cells per millilitre) or placebo were administered orally. The causes of the diarrhoea were viral rather than bacterial, but they were mainly unspecific infections. The median onset of treatment response (reduction of daily stool frequency to ≤ three watery or loose stools over at least 2 consecutive days) occurred more rapidly in the children receiving the EcN solution (2.5 days) than in those receiving the placebo (4.8 days), a significant difference (2.3 days; p = 0.0007). The number of patients showing a response was clearly higher (p < 0.0001) in the EcN group (52/55; 94.5%) than in the placebo group (39/58; 67.2%). EcN was found to be safe and well-tolerated, and it showed a significant superiority compared to the placebo in the treatment of acute diarrhoea in infants and toddlers.


Acute diarrhoea EcN Escherichia coli Nissle 1917 Infants Probiotic Toddlers