The probiotic Escherichia coli strain Nissle 1917 EcN stops acute diarrhoea in infants and toddlersReport as inadecuate

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European Journal of Pediatrics

, Volume 166, Issue 4, pp 311–318

First Online: 08 February 2007Received: 26 October 2006Revised: 20 December 2006Accepted: 29 December 2006


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 10 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.

KeywordsAcute diarrhoea EcN Escherichia coli Nissle 1917 Infants Probiotic Toddlers AbbreviationsADDPLANAdaptive Designs – Plans and Analyses

AEadverse event

BMIbody mass index kg-m

CIconfidence interval

CPMPCommittee for Proprietary Medicinal Products

EcNEscherichia coli strain Nissle 1917

EMEAEuropean Medicines Agency

ICHInternational Conference on Harmonization

IECIndependent Ethics Committee

IDMCIndependent Data Monitoring Committee

ITTintention to treat

PPper protocol

Electronic supplementary materialThe online version of this article doi:10.1007-s00431-007-0419-x contains supplementary material, which is available to authorized users.

Supported by ARDEYPHARM through the provision of verum and placebo medication and reimbursement of study-related expenditure. The authors would like to thank all hospital staff members, clinical monitors and parents for contributing to the work achieved.

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Author: Jobst Henker - Martin Laass - Boris M. Blokhin - Yuriy K. Bolbot - Vitaliy G. Maydannik - Martina Elze - Corinna Wolff -


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